BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI SD800.421 PEEK IMPLANT

    MDR report key: 4111798 · Received September 23, 2014

    Report

    Report Number
    1000562954-2014-10179
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 27, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    GXN
    PMA / PMN Number
    PK033868
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT NOT SATISFIED WITH HIS APPEARANCE. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A PATIENT IS NOT SATISFIED, AND IS EXPERIENCING EMOTIONAL FEELINGS, WITH THE APPEARANCE OF A PATIENT SPECIFIC IMPLANT (PSI) DESIGNED FOR ONLAY OF THE SKULL. THE PATIENT WAS REPORTED TO HAVE BEEN INVOLVED IN THE PLANNING, WHICH REQUIRED SEVEN DIFFERENT FORMS OF APPROVAL BEFORE HE WAS SATISFIED. THE PATIENT WAS REPORTED TO HAVE VERY HIGH EXPECTATIONS OF HIS CONFIDENCE AND SELF-ESTEEM BEFORE THE OPERATION AND NOW FEELS THAT THE PSI HAS NOT HELPED HIM AND STILL FEELS LOW. THE DEVICE IS STILL IMPLANTED IN THE PATIENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589769 PSI SD800.421 PEEK IMPLANT PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE GXN SYNTHES MEZZOVICO 9084435

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention