BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG UNIVERSAL DISTAL RADIUS PLATE

    MDR report key: 1871298 · Received October 15, 2010

    Report

    Report Number
    8010177-2010-00387
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 16, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K040022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT DISTAL RADIUS PLATE IS BROKEN. PT HAS NOT HAD REVISION AS OF YET BUT IS SCHEDULED FOR IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG UNIVERSAL DISTAL RADIUS PLATE IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other