BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI SD800.433 PEEK IMPLANT

    MDR report key: 3101745 · Received May 9, 2013

    Report

    Report Number
    2530088-2013-00780
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    GXN
    PMA / PMN Number
    K033868
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UPON REVIEWING THE DEVICE HISTORY RECORD FOR THIS IMPLANT, IT WAS DETERMINED THAT ALL DHR DOCUMENTS WERE PROPERLY COMPLETED, AND WERE SUFFICIENT TO SUPPORT THE DESIGN OF THE IMPLANT. BASED ON THIS REVIEW, IT WAS DETERMINED THAT THE DESIGN HISTORY RECORDS, INCLUDING FUNCTIONAL AND DESIGN REQUIREMENT AND RISK ANALYSIS, WERE SUFFICIENT AND WERE NOT THE CAUSE OF THE COMPLAINT. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE SURGEON COMPLAINING OF HEADACHE AND HARDWARE (PEEK IMPLANT) LOOSENING. REPORTEDLY THE PATIENT WAS TREATED FOR RIGHT TEMPORAL MENINGIOMA WHERE HIS ORIGINAL BONE FLAP RESORBED. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REVISION SURGERY. THE SURGEON REMOVED THE PEEK IMPLANT AND REVISED THE PATIENT TO A NEW PEEK IMPLANT. THIS IS 1 OF 5 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, A PATIENT WAS IMPLANTED WITH A PEEK IMPLANT (SD DEVICE) FOR RIGHT TEMPORAL MENINGIOMA. DURING FOLLOW-UP ON AN UNKNOWN DATE, THE SURGEON NOTED THE PEEK IMPLANT WAS LOOSE. A CT SCAN SHOWED POSSIBLE RESORBTION OF THE BONE AROUND THE IMPLANT, CAUSING THE IMPLANT TO BECOME LOOSE. SURGEON PLANNED TO REPLACE IMPLANT WITH A NEW IMPLANT WHICH WILL COMPENSATE FOR RESORBING BONE. SURGEON USED A MATRIX NEURO PLATE AND SCREWS TO FIXATE THE IMPLANT IN THE SKULL TEMPORARILY. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203924 PSI SD800.433 PEEK IMPLANT GXN SYNTHES BRANDYWINE 6844017

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention