BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI 100*60*40 PEEK

    MDR report key: 3052017 · Received April 11, 2013

    Report

    Report Number
    8030965-2013-01581
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 15, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GXN
    PMA / PMN Number
    K033868
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY THERE IS A 1-1.5MM VERTICAL GAP OR STEP SEEN UPON FITTING OF THE PSI IMPLANT IN THE FRONTAL AREA WHICH CAN BE FELT. IT WAS REPORTED THE IMPLANT IS NOT FLUSHED. THIS IS ESPECIALLY IMPORTANT IN THE FRONTAL AREA AS IT CAN BE FELT EASILY. THE SURGEON TRIED TO PUSH DOWN THE PSI TO MAKE THE IMPLANT AS FLUSHED AS POSSIBLE IN THE FRONTAL AREA AND IT WAS NOTED THAT THE GRADIENT IS NOT SATISFACTORY. THE POSTERIOR PORTION ROSE AND PRESENTED A GREATER VERTICAL GAP OF AROUND 4-5 MM. THE SURGEON TRIED HIS BEST TO PUSH THE WHOLE IMPLANT DOWN AND SECURED WITH OUR LPN. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154210 PSI 100*60*40 PEEK GXN SYNTHES GMBH 8236887

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention