BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PDL IMPLANT

    MDR report key: 2221564 · Received August 18, 2011

    Report

    Report Number
    2520274-2011-00561
    Event Type
    Injury
    Date Received
    August 18, 2011
    Report Date
    July 25, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SERVICE. 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 (B)(6) REPORTED, A CLINIC IN (B)(6) REPORTED: PT STATUS POST PRODISC-L IMPLANTATION, LEVELS UNKNOWN, ON (B)(6) 2005 RETURNED TO SURGEON COMPLAINING OF PAIN. AN X-RAY TAKEN ON AN UNKNOWN DATE SHOWED A DISLOCATION OF THE POLYETHYLENE INLAY. SURGEON REMOVED THE PRODISC-L ON (B)(6) 2011 AND REVISED THE PT TO SYNFIX. THIS IS THREE OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK - PDL IMPLANT POLYETHYLENE INLAY MJO SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 SUPERIOR ENDPLATE| INFERIOR ENDPLATE