BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 23723571 · Received December 4, 2025

    Report

    Report Number
    1644408-2025-01853
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 10, 2025
    Report Date
    March 17, 2026
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    KWS
    UDI-DI
    00190446822851
    PMA / PMN Number
    K233481
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEE H6, H10 AND H11 COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2025-00162; 508-65-001, S303-BROKE/CRACKED/DAMAGED, INSTRUMENT FAILURE IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    INSTRUMENT FAILURE - DURING PERIPHERAL SCREW PLACEMENT, 1 SCREW HOLE WOULD NOT LOCK IN ANY SCREW HEAD. MULTIPLE SCREWS WERE TRIED IN THAT HOLE AND NONE WOULD ENGAGE. THE BASEPLATE WAS INSPECTED PRIOR TO IMPLANTING AND THERE WAS NO APPARENT DAMAGE TO THE HOLE THREADS. THE HOLE WAS ULTIMATELY LEFT EMPTY. NO RISK REPORTED. BROKEN/FRAGMENTED PIECES LEFT PIECES LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2867663 DJO SURGICAL ALTIVATE REVERSE MOD BASEPLATE AND TAPER KIT, 6.5MM WEDGE KWS ENCORE MEDICAL L.P. 501A1186 00190446822851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention