BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L SUPERIOR PLATE

    MDR report key: 1910278 · Received November 23, 2010

    Report

    Report Number
    2530088-2010-00212
    Event Type
    Injury
    Date Received
    November 23, 2010
    Report Date
    October 26, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PRODISC-L IMPLANTED AT L5-S1 IN 2008 WAS WORKING PERFECTLY WHEN PATIENT DEVELOPED AN ONSET OF BACK PAIN SIX MONTHS POSTOP. FACET INJECTIONS PRESCRIBED ELIMINATED PAIN WITH SUBSTANTIAL IMPROVEMENT. PDL WAS REMOVED (B)(6) 2010 AND L5-S1 WAS FUSED. 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 SUPERIOR PLATE PRODISC-L SUPERIOR PLATE MJO SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention INFERIOR PLATE| POLYETHYLENE INLAY| POLYETHYLENE INLAY| INFERIOR PLATE