BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - US HALF DOSE 10-PK

    MDR report key: 2031531 · Received March 21, 2011

    Report

    Report Number
    9610726-2011-00080
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    January 15, 2011
    Report Date
    March 7, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    N17004
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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, "HOSPITAL DISCOVERED DAMAGE UPON RECEIVING AT THEIR LOADING DOCK AREA. (B)(6) HOSPITAL EMPLOYEE FOUND THE (B)(4) BOX HAD A HOLE AND UPON EMPTYING THE CONTENTS OF THAT BOX, NOTICED THE BOX PACKAGING, THE ABOVE PRODUCT ALSO WAS DAMAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P - US HALF DOSE 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA RLR184

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other