PRECICE® Intramedullary Limb Lengthening System P8.5-50D215Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00812258020583), received between Apr 15, 2020 and Nov 10, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THAT DURING EXPLANTATION, THE NAIL SEPARATED AND THE DISTAL PORTION WAS INITIALLY LEFT IN THE PATIENT'S BONE AS THE BONE CORTEX APPEARED TO HAVE CHANGED, WHICH RESULTED IN A REDUCED INTRAMEDULLARY CANAL SIZE. THE DISTAL PORTION WAS SUBSEQUENTLY RETRIEVED ANTEGRADE; HOWEVER, IT TOOK APPROXIMATELY 45 MINUTES TO RETRIEVE THE DISTAL PORTION. THERE WAS NO REPORT OF PATIENT INJURY OR FURTHER PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 18112539 ↗
• MalfunctionApr 24, 2023Migration; Migration

  INFORMATION WAS RECEIVED THAT THERE WAS DISLOCATION OF THE NAIL. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16800977 ↗
• MalfunctionJan 31, 2023Break; Break

  INFORMATION WAS RECEIVED THAT DURING A PLANNED REMOVAL PROCEDURE THE NAIL WAS FOUND TO BE CRACKED IN THE DISTAL ASPECT OF THE OUTER HOUSING. THE CRACK ON THE NAIL WAS NOTED TO EXTEND PROXIMAL ANOTHER 2-4CM. THE PATIENT REPORTED NO FALLS, IMPACTS, PAIN, OR OTHER NOTABLE EVENTS THAT WOULD CONTRIBUTE TO THE BREAKAGE. A PIECE OF THE HOUSING WAS MISSING FROM THE NAIL AND WAS LEFT INSIDE THE PATIENT'S MEDULLARY CANAL. THE SURGEON ATTEMPTED TO RETRIEVE THE REMAINING METAL PIECE IN THE MEDULLARY CANAL, BUT DECIDED TO PROCEED WITH INSERTING THE NEW TRAUMA NAIL WITHOUT SUCCESSFULLY REMOVING THE BROKEN PIECE.

  Patient problems: Failure of Implant

  MAUDE report 16273137 ↗
• MalfunctionJul 29, 2022Break; Break

  INFORMATION WAS RECEIVED THAT THE NAIL LENGTHENED ABOUT 3.5CM BEFORE IT WAS FOUND TO BE BENT. ALTHOUGH THE NAIL WAS FOUND TO BE BENT, THE PATIENT COMPLETED EXTENSION. HOWEVER, THE PATIENT IS NOW EXPERIENCING PAIN AS THE NAIL IS BROKEN AFTER THE PATIENT JUMPED INTO WATER. THE NAIL WAS EXPLANTED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15129605 ↗
• MalfunctionApr 18, 2022Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED THAT THE PATIENT PREMATURELY CONSOLIDATED AND ANOTHER OSTEOTOMY WAS PERFORMED. THE NAIL WAS REPORTED TO HAVE FAILED TO DISTRACT INTRA-OPERATIVELY. NO PATIENT ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137645 ↗
• InjuryApr 15, 2020Break; Break

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER, THE NAIL WAS BROKEN. REPORTEDLY, THE PATIENT WAS FULL WEIGHT BEARING BEYOND INSTRUCTIONS FOR USE.

  Patient problems: Failure of Implant

  MAUDE report 9965487 ↗