BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI SD800.427 PEEK IMPLANT

    MDR report key: 2993824 · Received March 8, 2013

    Report

    Report Number
    2530088-2013-00280
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    GXN
    PMA / PMN Number
    K033868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE REVIEW OF THE DESIGN HISTORY RECORD, ALL REQUIRED DOCUMENTS ARE PRESENT IN THE DHR. UPON REVIEW OF THE RISK ANALYSIS AND FUNCTIONAL / DESIGN REQUIREMENT, IT WAS DETERMINED THAT THIS DEVICE MET THOSE REQUIREMENTS, AND THESE REQUIREMENTS WERE NOT ATTRIBUTED TO THE CAUSE OF THE COMPLAINT.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP WITH THE SURGEON ON A CRANIOPLASTY PROCEDURE PERFORMED BY THE SURGEON, IT WAS REPORTED TO THE SALES CONSULTANT THAT THE PEEK PSI DID NOT FIT GREAT. THE IMPLANT REQUIRED REVISION WORK AND THE SURGEON THEN HAD TO TITANIUM GAP PLATE THE POSTERIOR DEFECT. THE SURGEON REPORTED THAT IT WAS A COMPLICATED IMPLANT. THE PATIENT ALSO HAS A PRE-EXISTING TITANIUM MESH IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99682 PSI SD800.427 PEEK IMPLANT GXN SYNTHES BRANDYWINE 7228280

    Patients

    Seq Age Sex Outcome Treatment
    1