BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL

    MDR report key: 2424593 · Received January 12, 2012

    Report

    Report Number
    1719045-2012-00011
    Event Type
    Malfunction
    Date Received
    January 12, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE MFG AND RAW MATERIAL RECORDS WERE REVIEWED AND REVEALED NO ISSUES THAT WOULD CONTRIBUTE TO THE COMPLAINT EVENT. THE DEVICE WAS RECEIVED AND IS IN THE EVAL PROCESS, NO CONCLUSION HAS BEEN DRAWN.

    Description of Event or Problem · 1

    DURING AN ANTERIOR FUSION LEVEL L2 TO L4, SURGEON WAS USING AN AWL TO MAKE HOLE FOR THE SCREWS AND THE TIP OF THE AWL BROKE OFF IN THE PT'S VERTEBRAL BODY AT L4. A CT SCAN CONFIRMED THE BROKEN PIECE, SURGEON WAS UNABLE TO RETRIEVE THE TIP OF THE AWL AND IT REMAINS IN THE PT'S BONE AT L4. A COMPETITORS PLATE AND SCREWS WERE ALSO REMOVED WITH THE EXCEPTION OF ONE COMPETITOR SCREW BROKE AND THE SHAFT REMAINS IN THE PT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AWL AWL HWJ SYNTHES MONUMENT 548390A05

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW| PLATE