BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G/K FE CROSS-SCREW D6,28XL50

    MDR report key: 392971 · Received May 3, 2002

    Report

    Report Number
    9610622-2002-00039
    Event Type
    Malfunction
    Date Received
    May 3, 2002
    Report Date
    February 5, 2002
    Manufacturer
    STRYKER TRAUMA GMBH
    Product Code
    HWC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DURING THE REMOVAL OF THE G/K SYSTEM, THE CROSS SREW BROKE. THE SURGEON HAD TO MAKE AN OPPOSITE INCISION IN ORDER TO REMOVE THE BROKEN END OF THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G/K FE CROSS-SCREW D6,28XL50 IMPLANT HWC STRYKER TRAUMA GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other