BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A.L.P.S. MVX¿

    MDR report key: 22440808 · Received July 8, 2025

    Report

    Report Number
    3012966183-2025-00016
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    May 14, 2025
    Report Date
    July 8, 2025
    Manufacturer
    TYBER MEDICAL
    Product Code
    HWC
    UDI-DI
    00196449010554
    PMA / PMN Number
    K232652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS EVALUATED AND INVESTIGATED WITH THE PROVIDED INFORMATION. NO IMAGES WERE PROVIDED AND THE DEVICE WAS DISCARDED BY THE HOSPITAL STAFF; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE CONDUCTED AS NO LOT-SPECIFIC INFORMATION WAS PROVIDED. A HISTORICAL DATA ANALYSIS CONCLUDED THERE ARE NO ESTABLISHED TRENDS OR CAPAS RELATED TO THE NATURE OF THIS EVENT DURING THE TIME OF THE INVESTIGATION. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE FROM THE COMPLAINANT. THE ROOT CAUSE CANNOT BE ESTABLISHED WITH THE PROVIDED INFORMATION.

    Description of Event or Problem · 0

    1.5MM MVX HAND PLATE WAS SELECTED, 1ST 1.5MM CORTEX SCREW WAS INSERTED INTO THE PLATE. 2ND SCREW GOT CORTICAL FIXATION, WHEN ADVANCING THE 1.5MM X 9MM SCREW THE HEAD SHEARED OFF. OPENED A BURR TO CUT AROUND THE BONE TO RETRIEVE THE SHAFT OF THE SCREW. INCREASE IN ANESTHESIA TIME FOR PATIENT AND EXTRA COSTS ADDED DUE TO OPENING UP BURRS, ETC TO REMOVE THE RETAINED SCREW SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844449 A.L.P.S. MVX¿ 1.5MM NON-LOCKING SCREW 9MM HWC TYBER MEDICAL 770150009 00196449010554

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Other