BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - CE TOBRA FD 10-PK

    MDR report key: 2920247 · Received December 17, 2012

    Report

    Report Number
    9610726-2012-00401
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 4, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

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

    Description of Event or Problem · 1

    THE WAREHOUSE ASSISTANT REPORTED THAT TWO PACKS OF 6197-1-010, LOT TJT060. DURING THE INSPECTION AT THE DISTRIBUTION SITE, THEY NOTED THAT THE PRODUCTS WERE DAMAGED. THE VIALS WITH THE LIQUID PART OF THE CEMENTS WERE BROKEN AND THERE WAS LEAKAGE OF LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P - CE TOBRA FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA TJT060

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other