BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW GAUGE

    MDR report key: 1190568 · Received October 2, 2008

    Report

    Report Number
    9610622-2008-00182
    Event Type
    Malfunction
    Date Received
    October 2, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 11, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE LONGER PIECE DISENGAGED FROM ITSELF, WAS IN THE PATIENT, REMOVED FROM PATIENT (ALL PIECES) USED A DIFFERENT DEPTH GAUGE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other