BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - US FULL DOSE 10-PK

    MDR report key: 2020517 · Received February 16, 2011

    Report

    Report Number
    9610726-2011-00044
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    N17004
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HOSP CLAIMS RECEIVED BOX OF SIMPLEX BONE CEMENT. ONE OF THE PACKS WAS BROKEN. THEY DESTROYED IT AS INSTRUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P - US FULL DOSE 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA RAS008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other