BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL TORQUE LIMITING ATTACHMENT AXSOS AO FIT

    MDR report key: 1905472 · Received November 10, 2010

    Report

    Report Number
    8031020-2010-00156
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 20, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    NURSE REPORTED VIA OUR SALES REP THAT SHE OBSERVED THAT THE UNIVERSAL TORQUE IS OUT OF FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL TORQUE LIMITING ATTACHMENT AXSOS AO FIT INSTRUMENT LXH STRYKER OSTEOSYNTHESIS SELZACH NA U22168

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other