BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC L - POLY INLAY 10 MM

    MDR report key: 1192766 · Received October 8, 2008

    Report

    Report Number
    1719045-2008-00137
    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

    ADD'L INFO HAS BEEN REQUESTED. NO INVESTIGATION COULD BE PERFORMED; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT A NUMBER.

    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 PRODISC L - POLY INLAY 10 MM PRODISC L - POLY INLAY MJO SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SUPERIOR PLATE| INFERIOR PLATE