PRECICE nail complications: every risk class with its published rate

It depends on what gets counted. Frost and colleagues (Acta Orthopaedica, 2023) reviewed 314 lengthening nails in 257 patients at Aalborg University Hospital and Nationwide Children's Hospital, 80 of them PRECICE, and logged every event down to a knee contracture that physiotherapy fixed. Result: 53% of patients had at least one complication. By severity, 26% had a type I event (minimal intervention), 35% a type II (substantial change of plan, often an unplanned operation), 4% a type IIIA (goal not reached) and 11% a type IIIB (new pathology or permanent sequelae).

The same group's 2021 systematic review pooled 41 papers and 983 segments, 747 of them PRECICE: 332 complications, or 34% of segments, split 11% type I, 15% type II, 5% type IIIA and 3% type IIIB. PRECICE-only studies averaged 31% per segment against 46% for FITBONE-only studies, a gap the 2023 cohort could not confirm after adjusting for age and bone (relative risk 0.9, not significant).

Single-center PRECICE series land on both sides. Frommer's 90 antegrade femoral nails in Münster (median age 15, leg-length discrepancy) reported complications in 76% of patients and unplanned surgery in 20%. Paley's 51 cosmetic stature patients, as tabulated in the 2020 Bone & Joint Research review, had 0.16 problems, 0.23 obstacles and 0.02 complications per patient. Same device, different definitions, different patients.

The implant is the most frequent source of PRECICE nail complications, and PRECICE nail failure is usually a mechanism or fixation problem rather than a broken implant. In the 314-nail cohort, device-related events occurred in 32% of segments (100 events): 22 distraction-mechanism failures, 29 attachment failures, 7 mechanical-strength failures and 42 others such as external-controller positioning problems. Not one of the 100 produced a type IIIA or IIIB outcome; the nails were revised or exchanged and the lengthening finished. In the 983-segment review the device accounted for 12% of segments, the distraction mechanism for 5%, and 1% of segments failed to reach the planned length for a device reason.

The manufacturer's instructions for use list the failure modes: loss of distraction, uncontrolled lengthening, failure to lengthen, implant bending, fracture, loosening and loss of fixation.

Bent and broken nails cluster in the cosmetic medical-tourism traffic. A 2025 Journal of Orthopaedics series from a US limb-lengthening center described 9 patients (22 lengthened bones) referred with complications after cosmetic lengthening, most of it performed abroad. Five bones (23%) had hardware failure, 3 bent and 2 broken, all femurs, and 4 of the 5 were fixed by exchange nailing. That is a referral sample, not an incidence rate. But a bent titanium nail was loaded past its yield point, which is what the weight-bearing rules below exist to prevent.

Joints are the second-largest source of PRECICE nail problems. Joint complications affected 23% of segments in the 314-nail cohort, contracture alone 16% (51 events, 10 graded type IIIB). Frommer's 90 femoral nails recorded temporary loss of knee motion in 20% of patients and hip motion in 2%, all resolved with physiotherapy; one patient (1%) had a knee subluxation. The PRECICE IFU itself cites a retrospective study with adjacent-joint motion loss in 4% of patients and subluxation in 6%.

The pattern follows the bone. Femoral lengthening pulls on the quadriceps and iliotibial band and stiffens the knee; tibial lengthening shortens the calf and drives the ankle into equinus. Frames make it worse because the wires transfix muscle: Novikov's 131 cosmetic Ilizarov patients had fixed knee flexion in 11% and ankle equinus in 9%. The nail removes the tethering, not the stretch.

The treatment is dull and non-negotiable: daily physiotherapy through distraction, knee-extension splinting for femurs, dorsiflexion work for tibias, and a surgeon willing to change the distraction rate when motion drops, which Frommer's team did in 27% of patients. A contracture caught early is a physiotherapy problem; caught late it is a surgical release. The cosmetic PRECICE series had exactly one complication in 51 patients: an iliotibial band contracture.

Bone complications are less frequent than device or joint events and more often serious. The 314-nail cohort logged 37 bone events (12% of segments): 16 delayed healings, 14 fractures, 3 premature consolidations and 3 secondary malalignments. The 983-segment review found bone problems in 8% of segments: delayed healing in 46 (about 5%), premature consolidation in 19 (2%) and fracture in 8.

Premature consolidation is the failure specific to a slow nail. The new bone bridges before the target length is reached, the magnetic drive cannot pull bridged bone apart, and the fix is a re-osteotomy. Frommer's series needed unplanned surgery for premature consolidation or insufficient distraction in 8% of patients (7 of 90) and recorded prolonged consolidation in 6%. Consolidation ran at a median 31 days per centimeter, so a 7 cm femur is healed roughly seven months after surgery on the median.

Two numbers drive the bone risk. Every extra millimeter raised complication risk by 1% in the Aalborg regression (RR 1.01 per mm), and a short-stature indication raised it by 50–80% against congenital cases. Cosmetic patients ask for the largest gains on the healthiest bones, and the data say the gain is what costs them. The US referral series is the extreme case: 9 of 22 bones (45%) arrived with a nonunion or malunion.

These are the events patients fear most, and they are the least frequent. Infection: 17 events in 314 nails (5%): 6 superficial, 4 deep soft-tissue, 3 osteomyelitis and 4 unclassified; in the 983-segment review, 8 infections (0.8%), 4 of them osteomyelitis; Frommer reported osteomyelitis in 3% (3 of 90). The frame comparison is narrower than clinic marketing suggests. Novikov's 131 Ilizarov patients had a deep-infection rate of 2.3% (3 patients), close to the nail cohorts' 0.5–3%. What disappears with a fully internal nail is the pin site: pin-tract infection was the most common problem across the frame and LON series in the 2020 review of 795 cosmetic patients.

Nerve injury: 7 neurological events in 314 nails (2%), including 2 cases of paralysis; 8 in 983 segments (0.8%), 5 of them paresthesia. Paley's 51 cosmetic PRECICE patients had 2 common peroneal neuropathies; Novikov's frame series had 6 (4.6%), one permanent. The tibia is the dangerous segment: tibial nails carried a 70% higher complication risk than femoral nails (RR 1.7) in the Aalborg data.

Blood clots: 3 vascular events in 314 nails (1%), one a deep vein thrombosis; 10 in 983 segments (1%), 4 of them DVTs; 1 DVT in the 51 cosmetic PRECICE patients. Both Frost papers grade DVT as type IIIB. Months on crutches after bilateral leg surgery is the kind of immobility clots follow; ask for the thromboprophylaxis protocol in writing.

Stryde was the stainless-steel PRECICE built for full weight-bearing, and it failed at the telescoping junction. The Münster group (Frommer et al., Bone & Joint Research, 2021) followed 57 consecutive Stryde lengthenings. Osteolysis beside the junction appeared on X-ray in 20 of 57 segments (35%) at a mean of 9.5 months, and 8 of those 20 patients had rest and walking pain. Of the first 24 retrieved nails, 20 (83%) showed macroscopic corrosion, with chromium the main metallic element in the debris. These Stryde-era PRECICE complications were a materials failure, not a mechanism failure.

The FDA record is recall Z-1323-2021: Class II, initiated by NuVasive on 12 February 2021 and posted 30 March 2021, covering all lots. It lists 2,360 units distributed worldwide, including Turkey, Germany, Greece, Spain, Saudi Arabia and the UAE, and gives the reason as "pain and bony abnormalities at the interface between the telescoping nail segments". Status in September 2026: open. Class II is the FDA's middle tier, not its most serious.

PRECICE 2 is titanium, a different alloy. The FDA's June 2023 letter says it is not aware of biocompatibility adverse events with titanium PRECICE devices while it continues to monitor; the IFU still lists metallosis, osteolysis and wear-debris reactions as possible events. PRECICE Max has its own open Class II recall (Z-0500-2025, initiated 30 September 2024, 164 devices in Florida and Nevada) for design, manufacturing and validation-documentation issues. A PubMed search for "PRECICE Max" in September 2026 returned one paper, about broken Stryde nails.

The label is blunt. The PRECICE IFU (LC0305 Rev D, March 2023) says the nail "cannot withstand the stresses of full weight bearing" in the femur or tibia, and bars activities that load more than 20% of body weight onto the treated limb during distraction. It caps patient weight at 57 kg for the 8.5–10.5 mm nails and, for most 10.7–12.5 mm configurations, 114 kg. Crutches or a walker are part of the device, not an optional extra.

The Aalborg regression gives the patient-side multipliers. Tibia versus femur: RR 1.7. Age 30–39 versus 10–19: RR 2.1; age 50–59: RR 2.6. Short-stature indication versus congenital: RR 1.5–1.8 depending on the model. Each millimeter lengthened: plus 1%. A 35-year-old man lengthening both tibias by 7 cm for height sits in every one of those higher-risk boxes at once. He cannot change his age; he can change the segment, the amount and the discipline.

Two more items belong on the checklist. The FDA's 2023 letter allows no more than two PRECICE devices in a patient at once, which puts simultaneous four-segment lengthening outside the label. And the nail is MR Unsafe for as long as it is in, which matters if you are injured or fall ill in the interim.

A PRECICE nail is temporary. The IFU says the device "should be removed after implantation time of no more than one year", and the FDA repeated that reminder to surgeons in June 2023. That means a second operation, a second anesthetic and a second bill, with its own risks.

Frost's team audited 271 elective nail removals (FITBONE, PRECICE and Stryde) in 225 patients. Complications occurred during 3% of removals, mostly hardware left behind or a nail that resisted extraction, and after 13% of them. The post-operative events were 18 cases of new knee pain (8% of retrograde femoral and 7% of tibial removals, all nails that came out through the knee joint) and 4 fractures, 2 needing surgery. By bone, 11% of femoral and 26% of tibial removals had a complication.

In practice removal happens close to the label: Frommer's group scheduled it one year after consolidation and had retrieved 92% of nails at a median of 17 months. Get the removal written into the quote, with the surgeon named and the location fixed, before the first operation. A clinic that quotes the implantation alone is quoting half the treatment.

The 2020 Bone & Joint Research review of 795 cosmetic stature patients gives the cleanest side-by-side, with two caveats: the implantable-nail figures come from a single series (Paley's 51 cosmetic PRECICE patients) and none of the differences reached statistical significance. Per patient, classic Ilizarov frames ran 0.7 problems, 1.5 obstacles and 0.2 complications; LON 1.1, 0.7 and 0.1; the implantable nail 0.16, 0.23 and 0.02. Mean gain was 5.6 cm with the nail against 6.4–7.6 cm with frames and LON, so the nail's better numbers partly reflect asking for less.

What the frame adds is pin-related: pin-tract infection as the leading problem, peroneal neuropathy in 4.6% and knee flexion deformity in 11% of Novikov's 131 patients, plus months of external hardware. What LON adds is a pin-to-nail contamination path and two operations. Magnetic nail complications are the device-failure column, a strict no-weight-bearing phase and a mandatory removal.

PRECICE nail complications, then, are mostly device and joint events that get fixed, with a 3–11% floor of permanent harm that no implant removes, a documented corrosion failure in the Stryde generation, and a removal operation built into the plan. The decisive variables in the data are the segment, the amount, the patient's age and the weight-bearing discipline; of those, only age is out of the patient's hands. Choose a surgeon who grades complications by a published system and will show you the log.