BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENDED VOLAR DR PLATE, WIDE, L, L81MM, 7HOLES

    MDR report key: 22676736 · Received July 31, 2025

    Report

    Report Number
    0008031020-2025-01314
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    July 7, 2025
    Report Date
    November 5, 2025
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    UDI-DI
    07613327614947
    PMA / PMN Number
    K233919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION - PLEASE REFER TO D9, THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT COULD BE CONFIRMED SINCE THE DEVICE WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE. THE RECEIVED PLATE WAS FOUND TO BE BROKEN FROM THE ROUND HOLE IN THE MIDDLE JUST ABOVE THE OBLONG HOLE. THE NATURE OF BREAKAGE EXHIBITED THE TYPICAL CHARACTERISTICS OF A FATIGUE FAILURE WITH SLIGHT PLASTIC DEFORMATION ALONG THE EDGES AND ON THE SURFACE, MOSTLY CAUSED DUE TO CONSTANT RUBBING UNDER GRADUAL SEPARATION. SIGNS OF HEAVY STRESS CONCENTRATION WERE OBSERVED ALONG ONE OF THE SIDES OF THE BROKEN SURFACE, EVIDENT BY SECONDARY FRACTURE LINE AND EDGES PRESSED BACK AGAINST THE SURFACE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. A COUPLE OF X-RAYS THAT WERE PROVIDED WERE PRESENTED TO OUR HCP WHO OPINED THAT THE FRACTURE IS STILL VISIBLE EVEN AFTER 12 WEEKS WITH HARDLY ANY SIGNS OF HEALING AND ALSO THE PLACEMENT OF PLATE COULD HAVE BEEN FURTHER OPTIMIZED. BASED ON THE AVAILABLE INFORMATION AND ABOVE INVESTIGATION, THE PLATE BROKE IN A FATIGUE MANNER WHERE THE ROOT CAUSE OF THE ISSUE IS MULTIFACTORIAL: THE LOCATION OF THE FRACTURE AND THE TECHNICAL ASPECTS OF THE SURGICAL PROCEDURE MOST LIKELY CONTRIBUTED TO THE EVENT. FURTHERMORE, PATIENT ACTIVITY LEVELS POST-OP MAY ALSO HAVE CONTRIBUTED TO AN INADEQUATE LOAD DISTRIBUTION AND THEREFORE, THE BREAKAGE OF THE IMPLANTS. THE IFU CLEARLY INSTRUCTS THE USER THAT: THESE DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNIONS AND/OR NON-UNIONS. INTERNAL FIXATION DEVICES ARE LOAD SHARING DEVICES WHICH ARE INTENDED TO HOLD FRACTURED BONE SURFACES IN APPOSITION TO FACILITATE HEALING. IF HEALING IS DELAYED OR DOES NOT OCCUR, THE APPLIANCE MAY EVENTUALLY BREAK DUE TO METAL FATIGUE. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND THE PATIENT¿S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE DEVICE. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INITIAL SURGERY ON THIS IMPLANT WAS DONE ON (B)(6), AND YESTERDAY WE DID A SURGERY TO REMOVE THE IMPLANT BECAUSE THE PLATE HAD BROKEN FROM THE SECOND TO MOST PROXIMAL SCREW PLATE BROKE IN HALF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INITIAL SURGERY ON THIS IMPLANT WAS DONE ON (B)(6) AND YESTERDAY WE DID A SURGERY TO REMOVE THE IMPLANT BECAUSE THE PLATE HAD BROKEN FROM THE SECOND TO MOST PROXIMAL SCREW PLATE BROKE IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2417675 EXTENDED VOLAR DR PLATE, WIDE, L, L81MM, 7HOLES PLATE, FIXATION, BONE HRS STRYKER GMBH 1000559155 07613327614947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention