BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM - 10 HOLE Y COMPRESSION PLATE

    MDR report key: 22692964 · Received August 1, 2025

    Report

    Report Number
    2027754-2025-00034
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    July 15, 2025
    Report Date
    November 10, 2025
    Manufacturer
    OSTEOMED, LLC
    Product Code
    HRS
    PMA / PMN Number
    K131445
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT DESCRIPTION IN THE COMPLAINT FORM READS THIS WAS A FOOT RIGID IMPLANT, ALTHOUGH THIS WAS FOR FIXATION OF THE WRIST. THE SURGEON STATED "THE PLATE WAS PLACED VOLAR ON THE SHAFT 2/3 OF THE RADIUS. THE PATIENT HAS TOO SMALL FOR US TO USE A 3.5 PLATE SO WE HAD TO USE THE 2.7 (EVEN THOUGH IT IS MEANT TO FIX FOOT FRACTURES. WE NEEDED OCCUPATIONAL THERAPY DUE TO LONG TERM IMMOBILIZATION OF THE WRIST (6 MONTHS) AND TO TRY AND STIMULATE BONE CONSOLIDATION. THE PATIENT STILL WORE REMOVABLE FOREARM SPLINTS ON DAILY BASIS REMOVING THEM FOR THERAPY AND BATHS." THIS PRODUCT IS NOT INTENDED TO BE IMPLANTED IN PEDIATRIC PATIENTS. TO DATE, THE DEVICE HAS NOT BEEN RETURNED. ALL INFORMATION RECEIVED HAS BEEN ACQUIRED THROUGH COMMUNICATION WITH THE SURGEON. IF AND WHEN THE DEVICE IS RETURNED AND THE INVESTIGATION YIELDS INFORMATION OUTSIDE OF USE ERROR, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT 336-2701 PLATE WITH BATCH NUMBER 1140167 WAS RECEIVED AND EXANIMATED ON NOVEMBER 04, 2025. AFTER A VISUAL INSPECTION THE BREAKAGE WAS IDENTIFIED ON THE FIRST COMPRESSION HOLE FROM THE Y END OF THE PLATE. A SLIGHT BEND IS OBSERVED ON THE PICTURE CLOSE UP, BUT NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A GRADUAL DEVIATION OF THE LEFT WRIST IN A 7 DAY LAPSE. PATIENT PAIN FREE. THE PATIENT AND FAMILY STATED THAT THE DEVIATION OCCURRED GRADUALLY FOR THE PAST 7 DAYS. WHEN THEY ARRIVED AT THE HOSPITAL, X RAYS WERE TAKEN AND THE PLATE WAS BROKEN AND THE BONE HAD NOT COMPLETELY HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183729 2.7MM - 10 HOLE Y COMPRESSION PLATE PLATE, FIXATION, BONE HRS OSTEOMED, LLC 336-2701 1140167

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention| O