BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 1497244 · Received September 1, 2009

    Report

    Report Number
    9610726-2009-00179
    Event Type
    Malfunction
    Date Received
    September 1, 2009
    Date of Event
    August 4, 2009
    Report Date
    August 4, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. AND WAS CLEARED (B) (4).

    Description of Event or Problem · 1

    DURING SURGERY, IT WAS FOUND THAT THERE WAS DAMAGE ON BOTH OF THE MONOMER'S PACKAGE OF TWIN PACK OF SIMPLEX. BOTH MONOMER'S PACKAGE HAD THE DAMAGE AT THE SAME PLACE (NEAR THE STERILE INDICATOR DOT). ANOTHER NEW SIMPLEX WAS USED WITHOUT PROBLEM. THERE WAS NO ADVERSE OUTCOME DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA JEQ016

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other