BEUDAMED
    FDA Adverse Event Other Summary report: N

    LARGE CUSTOM CRANIAL IMPLANT

    MDR report key: 1060871 · Received June 16, 2008

    Report

    Report Number
    8010177-2008-00040
    Event Type
    Other
    Date Received
    June 16, 2008
    Date of Event
    November 8, 2007
    Report Date
    May 20, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    GXN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER REP: FIRST IMPLANT WAS INSERTED. NO EXISTING INFECTIONS PRIOR OF FIRST SURGERY. THE INITIAL IMPLANT WAS TAKEN OUT IN 2008 AND PUT IN THE SECOND CI ON. INFECTION OCCURRED 18 DAYS LATER. CSF LEAK OCCURRED. TWO MONTHS LATER, CSF LEAK OCCURRED, SO 2ND CUSTOM CRANIAL IMPLANT WAS REMOVED. ANOTHER SURGERY IS TBD FOR ANOTHER CI IMPLANT TO INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE CUSTOM CRANIAL IMPLANT IMPLANT GXN STRYKER OSTEOSYNTHESIS FREIBURG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention