BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERIOR PLATE

    MDR report key: 1192767 · Received October 8, 2008

    Report

    Report Number
    1719045-2008-00136
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 8, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED. THE MANUFACTURING DATE HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE TWO LEVEL L4-S1 PRODISC-L WAS IMPLANTED IN 2003. THE TRANSLATION OF THE DEVICE REPORT INDICATES THE CAUSE FOR REVISION WERE FRONTAL MISPLACEMENT, INFECTION AND CONTINUED PAIN. THE ANGULATION (TILT) OF THE LEVEL WAS REVISED (BETWEEN 30 DEGREES AND 45 DEGREES). DURING REVISION IT WAS NOTED THAT THE UPPER PLATE HAD SLIPPED FORWARD CAUSING A DIFFICULT REMOVAL OF THE POLYETHYLENE INLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERIOR PLATE PRODISC-L SUPERIOR PLATES MJO SYNTHES MONUMENT NA 51172543

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INFERIOR PLATE| POLYETHYLENE INLAY