BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX-HYBRID AWL

    MDR report key: 1350725 · Received January 2, 2009

    Report

    Report Number
    9617544-2008-00260
    Event Type
    Malfunction
    Date Received
    January 2, 2009
    Date of Event
    November 21, 2008
    Report Date
    November 26, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HWJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE TIP SNAPPED OFF DURING SURGERY WHILE TIGHTENING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX-HYBRID AWL INSTRUMENT HWJ STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other