BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 24864592 · Received April 13, 2026

    Report

    Report Number
    1644408-2026-00689
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    KWS
    UDI-DI
    00190446844150
    PMA / PMN Number
    K233481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER (B)(4)_1644408-2025-00588; 804-06-324, 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.

    Description of Event or Problem · 0

    THE BLUE POST AUGMENT BASEPLATE INSERTER BROKE OFF INTO THE PATIENT. THE SURGEON TRIED TO REMOVED THE BLUE POST WITH A BURR BUT WAS UNSUCCESSFUL AND THE BLUE POST WAS PUSHED FURTHER INTO THE GLENOID. THE SURGEON DECIDED TO LEAVE THE BLUE TIP INTO THE GLENOID. HE REIMPLANTED THE BASEPLATE WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564700 DJO SURGICAL ALTIVATE REVERSE GLENOID BASEPLATE INSERTER, WEDGE KWS ENCORE MEDICAL LP 804-06-324 410796L02 00190446844150

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention