PRECICE® Intramedullary Limb Lengthening System P10.7-80D305Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00812258020668), received between Sep 13, 2016 and Aug 7, 2024 — classified as 4 injuries, 3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2024Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  INFORMATION WAS RECEIVED THAT DURING THE IMPLANT PROCEDURE THAT NAIL FAILED TO LENGTHEN PROPERLY AND NEEDED TO BE REPLACED. DUE TO THIS, THE SURGERY WAS LONGER THAN EXPECTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934208 ↗
• MalfunctionJun 27, 2024Failure to Advance; Failure to Advance

  INFORMATION WAS RECEIVED THAT THE NAIL WAS UNABLE TO DISTRACT WHEN TESTED IN-SITU OR WHEN IT WAS EXPLANTED. IT IS BELIEVED THE NAIL STOPPED WORKING DUE TO IMPACTION. THE SURGERY WAS COMPLETED WITH NO ISSUE OR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 19625152 ↗
• InjuryNov 14, 2023Break; Failure to Advance; Break; Failure to Advance

  INFORMATION WAS RECEIVED THAT THE NAIL BROKE DURING LENGTHENING. PER THE REPORTER, THE NAIL STOPPED LENGTHENING AFTER 30MM AND IT WAS FOUND VIA X-RAYS THAT THE CROWN IN THE DISTAL PART OF THE NAIL HOUSING WAS BROKEN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 18136939 ↗
• MalfunctionSep 12, 2022Break; Break

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED DUE TO THE PATIENT NEEDING A NEW OSTEOTOMY IN THE FEMUR TO ACHIEVE LENGTHENING GOALS. DURING THE REVISION IT WAS NOTICED THAT THE NAIL WAS BROKEN AT THE TOP PORTION OF THE BEND NEAR THE SCREW HOLES. DUE TO THE CONDITION OF THE NAIL, IT WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15404539 ↗
• InjuryJun 13, 2022Crack; Fracture; Crack; Fracture

  INFORMATION WAS RECEIVED THAT DURING A PHYSIOTHERAPY SESSION, THE NAIL'S HOUSING TUBE CRACKED AT THE JUNCTION OF THE HOUSING TUBE AND DISTRACTION ROD, AND THE CROWN OF THE NAIL FRACTURED. AS PER THE REPORTER, THERE WAS LOSS OF ROTATIONAL STABILITY. THE NAIL WAS REMOVED; THERE WAS NO FURTHER ADVERSE PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14681507 ↗
• MalfunctionApr 18, 2022Break; Break

  INFORMATION WAS RECEIVED THAT DURING EXPLANTATION THE NAIL DISASSOCIATED AND THE CROWN CAME OFF. ALL FRAGMENTS OF THE NAIL WERE EXPLANTED AND THE PATIENT OUTCOME WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137683 ↗
• InjurySep 13, 2016Material Separation

  A DISTRIBUTOR REPORTED THAT A PATIENT'S PRECICE NAIL WAS REMOVED AFTER APPROXIMATELY FIVE (5) MONTHS OF IMPLANTATION. THE PATIENT HAD ACHIEVED FULL LENGTHENING OF APPROXIMATELY 6CM; HOWEVER, AFTER VIEWING X-RAYS, THE NAIL ALLEGEDLY APPEARED TO HAVE SEPARATED.

  Patient problems: No Information

  MAUDE report 5946339 ↗