BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - US TOBRA FD 10-PK

    MDR report key: 2110159 · Received May 19, 2011

    Report

    Report Number
    9610726-2011-00165
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(4) DAMAGED THE CASE WITH THE BONE CEMENT IN IT. WHEN OPENED AT THE HOSPITAL, THERE WAS LIQUID IN THE BOTTOM OF THE BOX AND THAT THE SMELL WAS SO BAD THAT THE BOX HAD TO BE IMMEDIATELY CLOSED. HOSPITAL WAS TOLD TO DISPOSE THE PRODUCT.

    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 MDS028

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other