BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - US TOBRA FD 10-PK

    MDR report key: 1884542 · Received October 21, 2010

    Report

    Report Number
    9610726-2010-00381
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL ORDERED CEMENT. THEY RECEIVED 4 BOXES AND ONE OF THE 4 BOXES WAS DAMAGED. IT WAS FURTHER REPORTED THAT THE MATERIALS MANAGEMENT SMELLED THE MONOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P - US TOBRA FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA MHR043

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other