BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED ?5X50 MM

    MDR report key: 1060908 · Received June 13, 2008

    Report

    Report Number
    9610622-2008-00088
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 23, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED WILL BE SUPPLIED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IMPLANT SURGEON, REPORTED VIA OUR SLES REP, THAT A MALE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE SCREW FRACTURING 6 WEEKS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED ?5X50 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K495308

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention