BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, SHO

    MDR report key: 1202749 · Received October 9, 2008

    Report

    Report Number
    8010177-2008-00068
    Event Type
    Other
    Date Received
    October 9, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS EVENT IS CONTINUATION OF (B) (4). THE SURGEON WAS MONITORING FOR THE PT, AND THE SURGEON FOUND THAT THE PT BONE WAS MALUNION. ON (B) (6) 2008, THE SURGEON REMOVED THE PLATE AND SCREWS AND HE REQUESTED THE INVESTIGATION OF THE PLATE AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, SHO IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG J3R00F1671

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention