BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORSAL SMARTLOCK DR PLATE, WIDE, LEFT

    MDR report key: 2000989 · Received February 18, 2011

    Report

    Report Number
    8010177-2011-00052
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K040022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. INTERNAL INVESTIGATION IN PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE HARDWARE FAILURE WAS DUE TO NON-UNION OF THE FRACTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORSAL SMARTLOCK DR PLATE, WIDE, LEFT IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG NA L7P00F1758

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention