BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L SUPERIOR PLATE

    MDR report key: 2070400 · Received April 19, 2011

    Report

    Report Number
    8030965-2011-00197
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    April 11, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PROVIDE THE PMA/510K NUMBER AND/OR THE DATE OF MANUFACTURE AS NO PRODUCT HAS RETURNED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM WALDENBURG INDICATES: A PT FROM (B)(6) WAS IMPLANTED WITH PRODISC-L AT LEVELS L4-5 AND L5-S1. PT RETURNED TO SURGEON COMPLAINING OF CONTINUING LOW BACK PAIN. SURGEON REMOVED THE PDL AT L5-S1 AND REPLACED WITH VISIOS 9 MM IMPLANT. THIS IS TWO OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-L SUPERIOR PLATE PRODISC-L SUPERIOR PLATE MJO SYNTHES (USA) NA 3267205

    Patients

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