BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - CE ABC FD 10-PK

    MDR report key: 2020482 · Received February 16, 2011

    Report

    Report Number
    9610726-2011-00038
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    PHARMACIST REPORTED THAT "AT RECEIPT OF THE PRODUCT, THE AMPOULE WAS BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P - CE ABC FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA BLR038

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other