BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORSAL MEDIAL DISTAL RADIUS PLATE, SHORT, RIGHT

    MDR report key: 2121811 · Received May 20, 2011

    Report

    Report Number
    8010177-2011-00141
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K040022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    AS THE SALESMAN REPORTED, 2 DISTAL RADIUS PLATES (B)(4) WERE FOUND BROKEN INSIDE ONE PATIENT, WHO HAD A DISTAL RADIUS SURGERY SOME MONTHS AGO. BOTH PLATES WERE REMOVED FROM THE PATIENT. THE AREA WHERE THE PLATES WERE IMPLANTED WAS VERY DAMAGED. IT SEEMS THAT THE PLATES DAMAGED THE BONE AND ALSO THE AREAS NEAR TO THE ZONE WHERE THE PLATES WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORSAL MEDIAL DISTAL RADIUS PLATE, SHORT, RIGHT IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK