BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM HYBRID SCREWDRIVER TUBE

    MDR report key: 1111960 · Received August 11, 2008

    Report

    Report Number
    9617544-2008-00075
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HXX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE CUSTOM INSTRUMENT BROKE WHILE IN SURGERY. THE TIP OF THE SCREWDRIVER BROKE WHILE LOADING THE SCREW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM HYBRID SCREWDRIVER TUBE INSTRUMENT HXX STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other