BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXATION SCREW

    MDR report key: 1944707 · Received December 9, 2010

    Report

    Report Number
    9610622-2010-00524
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 23, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    NURSE REPORTED, VIA SALES REP, THAT THE SURGEON WAS NOT ABLE TO SCREW THE SCREWS INTO THE TARGET DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXATION SCREW INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other