BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING INSERT AXSOS 5.0MM LOCKING SET

    MDR report key: 1981634 · Received January 12, 2011

    Report

    Report Number
    8031020-2011-00004
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K062066
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. SAME PATIENT EVENT AS MDR 8031020-2011-00005.

    Description of Event or Problem · 1

    IT WAS REPORTED, LOCKING SCREW AND INSERT PULLED OUT AFTER COMPRESSION WAS DONE WITH PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING INSERT AXSOS 5.0MM LOCKING SET IMPLANT KTT STRYKER OSTEOSYNTHESIS SELZACH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other