BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10NM TORQUE LIMITING HANDLE

    MDR report key: 1861951 · Received October 5, 2010

    Report

    Report Number
    1719045-2010-00275
    Event Type
    Injury
    Date Received
    October 5, 2010
    Report Date
    September 7, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION IS ON-GOING. NO CONCLUSION CAN BE DRAWN A THIS TIME.

    Description of Event or Problem · 1

    SURGEON HAS INDICATED HE HAS HAD SEVERAL CONSTRUCTS COME APART POST OPERATIVE, DUE TO CALIBRATION ISSUES WITH THE TORQUE LIMITING HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10NM TORQUE LIMITING HANDLE 10NM TORQUE LIMITING HANDLE LXH SYNTHES MONUMENT NA 566944J06-211

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention