BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L POLYETHYLENE INLAY

    MDR report key: 2090007 · Received May 6, 2011

    Report

    Report Number
    8030965-2011-00215
    Event Type
    Injury
    Date Received
    May 6, 2011
    Report Date
    April 29, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A PART NUMBER OR A LOT NUMBER. INVESTIGATION COULD NOT BE CONCLUDED AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    PT IMPLANTED WITH PRODISC-L AT L5-S1 ON (B)(6) 2010. PT EXPERIENCED PERSISTENT BACK PAIN, RADICULAR PAIN IN BOTH LEGS AND NEUROLOGICAL COMPRESSION. PRODISC-L REMOVED (B)(6) 2011. IMPLANT INTACT, NOTED AS TOO LARGE BY OPERATIVE SURGEON. POLYETHYLENE INLAY REMOVED WITH SOME DIFFICULTY NOTED. BOTH END PLATES REMOVED. 8MM SMALL BAGUERA PLACED, REVISION COMPLETED. THIS IS THE 3RD OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-L POLYETHYLENE INLAY PRODISC-L IMPLANT MJO SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SUPERIOR ENDPLATE| INFERIOR ENDPLATE