BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L IMPLANT SUPERIOR ENDPLATE

    MDR report key: 2042132 · Received March 30, 2011

    Report

    Report Number
    8030965-2011-00132
    Event Type
    Injury
    Date Received
    March 30, 2011
    Report Date
    March 25, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MFG SITE OR MFG DATE WITHOUT A PART NUMBER OR A LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PT IMPLANTED WITH PRODISC-L AT L5-S1 ON (B)(6) 2007. PT COMPLAINED OF PAIN AFTER 2.5 YEARS. X-RAYS SHOWED DISLOCATION IN VENTRAL. PRODISC-L WAS REMOVED ON (B)(6) 2011. THIS IS THE 1ST OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

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

    Patients

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