BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI PLATE, 4-HOLES, STRAIGHT (1/P)

    MDR report key: 1940682 · Received December 22, 2010

    Report

    Report Number
    8010177-2010-00476
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 29, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K014263
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    REP WAS CALLED REGARDING A REVISION SURGERY FOR AN INFECTED SITE CONTAINING STRYKER PRODUCTS. ORIGINAL SURGERY INFO IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI PLATE, 4-HOLES, STRAIGHT (1/P) IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention