BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 1160475 · Received September 12, 2008

    Report

    Report Number
    9610726-2008-00061
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 14, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    N17004
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2008, THE PT HAD PRIMARY SURGERY TO REMOVE THE INTERCEREBRAL HEMATOMA. STRKYER'S PLATE AND SCREWS AND CEMENT (SIMPLEX) WAS USED TO CLOSE THE CRANIUM. (THE CEMENT WAS APPLIED TO THE INCISION DIMENSION OF THE CRANIUM). BEFORE SURGERY, THE SURGEON HAD NOT CONFIRMED WHETHER OR NOT THE PT WAS ALLERGIC TO METAL. ONE MONTH POST-OP, PT DEVELOPED (PRURITIC) EDEMATOUS AREA ON PART OF HIS/HER FACE AND HEAD. THE SURGEON PERFORMED AN ALLERGY PATCH TEST AND FOUND THAT THE PT WAS ALLERGIC TO METAL. IT IS UNK WHICH METAL THEY ARE ALLERGIC TO. (IN ANOTHER COUNTRY, THE USE OF CEMENT TO CRANIUM IS NOT INDICATION OF THE CEMENT (SIMPLEX). IT IS UNK WHETHER THE SURGEON WAS AWARE OF THIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other