BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, RIG

    MDR report key: 2193461 · Received December 17, 2009

    Report

    Report Number
    8010177-2009-00226
    Event Type
    Malfunction
    Date Received
    December 17, 2009
    Date of Event
    November 16, 2009
    Report Date
    November 20, 2009
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K062498
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN (B)(6) FEMALE PT UNDERWENT A REVISION SURGERY DUE TO THE PLATE FRACTURING 3 WEEKS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAR RADIUS FRACTURE PLATE, LOCKING, MEDIUM, RIG IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG NA GB700F1622

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention