BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE

    MDR report key: 2800437 · Received October 17, 2012

    Report

    Report Number
    2530088-2012-00940
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR WHAT HAPPENED IN THIS CASE WITH THE PROVIDED INFO. IT IS NOT CLEAR WHETHER THE IMPLANT WAS PLACED FAR ENOUGH POSTERIORLY AT THE TIME OF IMPLANTATION OR IF IT MOVED IN-VIVO. THIS IMPLANT HAS BEEN SHOWN TO WITHSTAND NORMAL PHYSIOLOGIC LOADING IN THE CERVICAL SPINE AND THE PROPER INSERTION TECHNIQUE IS EXTENSIVELY COVERED IN THE TECHNIQUE GUIDE AS WELL AS IN MANDATORY SURGEON TRAINING. THE DESIGN RISK ASSESSMENT WAS REVIEWED AND WAS FOUND TO BE ADEQUATE FOR THE INTENDED USE. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED AS TREATMENT. THE RAW MATERIAL AND DEVICE HISTORY RECORDS WERE REVIEWED AND NO NONCONFORMITIES WERE FOUND. THE REVIEW OF THE RECORDS SHOWS THAT THE PARTS WERE PROCESSED WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. INFORMATION FROM RECEIVED QUESTIONNAIRE.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE IMPLANT WAS INTACT UPON REMOVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SYNTHES: SURGEON PERFORMED A PRODISC-C REMOVAL IT WAS REPORTED THAT THE PRODISC-C IMPLANT WAS REMOVED FROM LEVEL C5-6 BECAUSE IT WAS COMING OUT OF THE VERTEBRAL BODIES. SUBSEQUENTLY, THE SURGEON PERFORMED A FUSION ON THE PT FOLLOWING THE IMPLANT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE PRODISC-C IMPLANT MJO SYNTHES BRANDYWINE 6784157

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention