BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-US TOBRA FD 10-PK

    MDR report key: 2934107 · Received December 19, 2012

    Report

    Report Number
    9610726-2012-00409
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VIAL OF MONOMER WAS BROKEN WHEN STAFF OPENED THE BOX. CEMENT WAS DISPOSED OF.

    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 MIT083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other