BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A.L.P.S. MVX¿

    MDR report key: 21777916 · Received April 4, 2025

    Report

    Report Number
    3012966183-2025-00008
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Report Date
    April 4, 2025
    Manufacturer
    TYBER MEDICAL
    Product Code
    HRS
    UDI-DI
    00196449015894
    PMA / PMN Number
    K232652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS INVESTIGATED THROUGH HISTORICAL DATA ANALYSIS, AN INTERVIEW WITH THE ASSOCIATED SALES REP, AND A RADIOGRAPHICAL REVIEW CONDUCTED VIA A 3RD PARTY SURGEON. RADIOGRAPHS AND OTHER IMAGES WERE ANALYZED BY A 3RD PARTY SURGOEN AND CONCLUDED THAT THE PLATE WAS DESIGNED FOR LOAD SHARING AND NOT FOR SUPPORTING SEGMENTAL DEFECTS ON ITS OWN. THE ACTUAL DEVICE WAS NOT RETURNED FOR TESTING; THEREFORE A DEVICE EVALUATION WAS UNABLE TO BE PERFORMED. NO LOT INFORMATION HAS BEEN MADE AVAILABLE; THEREFORE A DEVICE HISTORY RECORD RETURNED INCONCLUSIVE RESULTS. AT THE TIME OF THE INVESTIGATION, THERE WERE NO TRENDS OR CAPAS RELATED TO THE NATURE OF THIS COMPLAINT. WITH THE CURRENT INFORMATION, A ROOT CAUSE OF THE PLATE FRACTURE CAN BE TRACED TO COMPONENT FAILURE, AS THE PLATE WAS BEING USED TO SUPPORT SEGMENTAL DEFECTS. IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT SHALL BE SUBMITTED.

    Description of Event or Problem · 0

    SALES REP STATED THAT THE INITIAL CASE WAS COMPLETED IN END JUNE/EARLY JULY. IT WAS A 23 YR OLD FEMALE APPROX 180 LBS. THE MECHANISM OF INJURY WAS A GUNSHOT WOUND TO THE ANKLE. SHE STATED THERE WAS ANKLE WAS A MESS AND THE SURGEON SAID HE EXPECTED HEALING MAY BE AN ISSUE. THE FACTURE WAS A NON-UNION WHICH IS WHY THE PLATE EVENTUALLY BROKE. THE SURGEON CUT OUT THE BAD BONE, FILLED IT WITH BONE CEMENT AND PLACED ANOTHER AL TIBIA PLATE IN THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979540 A.L.P.S. MVX¿ ANTLATERAL TIB PLT 10H LT WIDE HRS TYBER MEDICAL 770714101 00196449015894

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention| O