PRECICE® Intramedullary Limb Lengthening System P12.5-80D305Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00812258020736), received between Jul 30, 2020 and Jul 8, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 reports).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 29, 2021Class IIOpen, Classified

   The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.

   Z-0319-2022 · Root cause: Device Design · Recall details · FDA record ↗

2. Feb 12, 2021Class IIOpen, Classified

   Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

   Z-1349-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2024Failure to Advance; Failure to Advance

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19695309 ↗
• MalfunctionJul 8, 2024Failure to Advance; Failure to Advance

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 19693490 ↗
• MalfunctionJun 20, 2023Failure to Advance; Failure to Advance

  INFORMATION WAS RECEIVED THAT AT THE FIRST FOLLOW UP APPOINTMENT IT WAS NOTED VIA X-RAYS THAT THE NAIL DID NOT CONTINUE TO LENGTHEN AT THE APPROPRIATE RATE AND DISTANCE. CHANGES SEEN ON THE X-RAY WERE INDICATIVE THAT THE NAIL WAS NOT FUNCTIONING PROPERLY; RATHER THAN MOVING DISTALLY, ONE OF THE INTERNAL SCREWS WAS MOVING PROXIMALLY INSIDE THE ROD. THE PATIENT UNDERWENT A REVISION TO REPLACE THE MALFUNCTIONING NAIL AND THE CORRECTIVE PROCEDURE WAS PERFORMED 10 DAYS LATER WITHOUT COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 17164591 ↗
• InjuryApr 24, 2023Failure to Advance; Defective Device; Failure to Advance; Defective Device

  INFORMATION WAS RECEIVED THAT THERE WAS AN UNSPECIFIED IMPLANT FAILURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16798709 ↗
• InjuryAug 17, 2022Fracture; Fracture

  INFORMATION WAS RECEIVED THAT THE NAIL FRACTURED IN-SITU. THE PATIENT WAS REPORTEDLY ENGAGING IN FULL WEIGHT-BEARING ON THE NAIL WITHOUT BONE CONSOLIDATION STRONG ENOUGH TO SUPPORT NORMAL GAIT MOVEMENT. THE PATIENT CLAIMED THEY FELT A POP DURING MOVEMENT AND THE NAIL WAS SUBSEQUENTLY FOUND TO HAVE A CLEAN BREAK THROUGH THE CENTER OF THE NAIL AT THE SITE OF ORIGINAL OSTEOTOMY. THE PATIENT UNDERWENT A REVISION SURGERY; HOWEVER, NO FURTHER ADVERSE IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15246143 ↗
• MalfunctionFeb 16, 2022Collapse; Crack; Collapse; Crack

  INFORMATION WAS RECEIVED THAT THE PATIENT HAD FINISHED LENGTHENING AND WAS IN THE CONSOLIDATION PHASE WHEN THE CROWN CRACKED AND THE NAIL COLLAPSED. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545962 ↗
• MalfunctionJul 30, 2020Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT A PROCEDURE WAS PERFORMED POST SUCCESSFUL LENGTHENING. AS PER THE REPORTER, AFTER REMOVAL IT WAS OBSERVED THAT THE NAIL HAD CRACKED/FRACTURED NEAR THE MOST DISTAL PART OF THE FEMALE PORTION OF THE NAIL. THE NAIL WILL NOT BE RETURNING FOR EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 10345215 ↗