BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERIOR PLATE LARGE

    MDR report key: 1040049 · Received May 8, 2008

    Report

    Report Number
    2530088-2008-00028
    Event Type
    Injury
    Date Received
    May 8, 2008
    Report Date
    April 11, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    PMA / PMN Number
    PO50010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    PRODISC L WAS IMPLANTED AT L5-S1, REPORTEDLY OVERLAID WITH A GORTEX PATCH AS AN ANTI ADHESION BARRIER. PT EXPERIENCED CONTINUED PAIN POSTOPERATIVELY; PRODISC L WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERIOR PLATE LARGE PRODISC L SUPERIOR PLATE MJO SYNTHES (USA) NA 5472824

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention POLYETHELENE INLAY| INFERIOR PLATE LARGE| GORTEX PATCH