PRECICE® Plating System LP4.5-PRF4BRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887517021366), received between Jun 22, 2021 and Nov 30, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Corroded” (6 reports).

3 FDA recall records name this device's identifier, 3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 29, 2021Open, 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 · FDA record ↗

2. Feb 12, 2021Open, Classified

   Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

   Z-1325-2021 · Root cause: Under Investigation by firm · FDA record ↗

3. Feb 12, 2021Open, Classified

   Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.

   Z-1323-2021 · Root cause: Under Investigation by firm · 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 30, 2021Corroded; Corroded

  DURING ROUTINE REMOVAL OF THE PLATE AFTER THE LENGTHENING GOAL HAD BEEN ACHIEVED, CORROSION WAS DISCOVERED ON THE PLATE USED ON THE LEFT TIBIA. THE CORROSION WAS NOTED AROUND PLATE'S MALE/FEMALE JUNCTION AND SELECT SCREW SITES. AT THE TIME OF THE REMOVAL, IT WAS ALSO NOTED THAT THERE WAS A DELAYED UNION OF THE REGENERATE IN THE LEFT TIBIA; HOWEVER, NO OSTEOLYSIS WAS FOUND. A LOW PROFILE STATIC LOCKING PLATE WAS IMPLANTED TO PROVIDE EXTENDED SURGICAL SITE STABILITY AND PRESERVE NEW BONE LENGTH. NO PATIENT HARM OR ADVERSE IMPACT IS ASSOCIATED WITH THIS EVENT.

  Patient problems: Impaired Healing; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12899367 ↗
• MalfunctionNov 30, 2021Corroded; Corroded

  DURING ROUTINE REMOVAL OF THE PLATE AFTER THE LENGTHENING GOAL HAD BEEN ACHIEVED, CORROSION WAS DISCOVERED ON THE PLATE USED ON THE RIGHT TIBIA. THE CORROSION WAS NOTED AROUND PLATE'S MALE/FEMALE JUNCTION AND SELECT SCREW SITES. NO PATIENT HARM OR ADVERSE OUTCOME IS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12899292 ↗
• MalfunctionSep 20, 2021Corroded; Material Twisted/Bent; Corroded; Material Twisted/Bent

  IT WAS REPORTED THAT UPON PLANNED REMOVAL OF THE PRECICE PLATE AFTER LENGTHENING GOALS WERE SUCCESSFULLY ACHIEVED AND THERE WAS RADIOGRAPHIC EVIDENCE OF QUALITY REGENERATE BONE/CONSOLIDATION, IT WAS NOTED THE PLATE HAD VISIBLE SIGNS OF CORROSION AROUND THE SCREW HOLES IN THE DISTRACTION ROD SIDE OF THE PLATE. NO ADVERSE PATIENT IMPACT WAS NOTED AND THE SURGEON WILL CONTINUE WITH THE PLANNED POST-OP FOLLOW UP VISITS/PATIENT MONITORING PROTOCOL. IT WAS ALSO REPORTED THAT THE PATIENT HAD BEEN PARTIALLY WEIGHT-BEARING IN THE LATE CONSOLIDATION PHASE OF TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497601 ↗
• InjuryJul 27, 2021Corroded; Corroded

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12233285 ↗
• MalfunctionJul 7, 2021Corroded; Corroded

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132628 ↗
• MalfunctionJun 22, 2021Corroded; Material Discolored; Corroded; Material Discolored

  INFORMATION WAS RECEIVED THAT DURING IMPLANT REMOVAL PROCEDURE, IT WAS DISCOVERED THAT THE PLATE HAD VISIBLE DISCOLORATION AND CORROSION. AT THE TIME OF REMOVAL, A LOW PROFILE NAIL WAS INSERTED FOR EXTRA STABILITY. THE DESIRED LENGTH WAS ACHIEVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12044921 ↗