PRECICE® Plating System LP4.5-MLT4BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887517021687), received between Feb 22, 2021 and Mar 30, 2021 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT A SUPERFICIAL WOUND INFECTION WAS DIAGNOSED. THE INFECTION IS BELIEVED TO BE THE RESULT OF PROMINENT HARDWARE IN AN AREA OF LIMITED SOFT TISSUE COVERAGE. ADDITIONALLY, THE TENSION OF THE SOFT TISSUE OVER THE PLATE INCREASED AND CONTRIBUTED TO WOUND BREAKDOWN.

  Patient problems: Deformity/ Disfigurement; Unspecified Infection

  MAUDE report 11589054 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT REMOVAL PROCEDURE WAS PERFORMED (B)(6) 2020 DUE TO WOUND BREAKDOWN. AS PER THE REPORTER, THE WOUND WAS IRRIGATED AND DEBRIDED. THE PATIENT WAS SWITCHED TO EXTERNAL FIXATION TO COMPLETE THEIR LENGTHENING TREATMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 11363723 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT AN OSTEOTOMY REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020 FOR PREMATURE CONSOLIDATION ENCOUNTERED 2 CM INTO LENGTHENING. AS PER THE SURGEON, THE EVENT WAS THE RESULT OF SURGEON ERROR, SPECIFICALLY ASSOCIATED WITH INADEQUATE RADIOGRAPHIC ASSESSMENT AND RATE OF CORRECTION AT THE TIME OF FOLLOW UP.

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

  MAUDE report 11363720 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER, THE PATIENT NEEDED AN OSTEOTOMY IN ORDER TO CONTINUE THE LENGTHENING TREATMENT AFTER RECOVERING FROM COMPARTMENT SYNDROME.

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

  MAUDE report 11363718 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT A FOLLOW UP NERVE RELEASE/ FASCIOTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2020. AS PER THE REPORTER, THE PATIENT DEVELOPED COMPARTMENT SYNDROME.

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

  MAUDE report 11363716 ↗