BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L INFERIOR PLATE

    MDR report key: 1905793 · Received November 18, 2010

    Report

    Report Number
    2530088-2010-00200
    Event Type
    Injury
    Date Received
    November 18, 2010
    Report Date
    October 19, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. DEVICE WAS NOT EXPLANTED. 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

    PT IMPLANTED WITH PRODISC-L AT L4-L5 ON AN UNK DATE, SUBSEQUENTLY RETURNED TO OPERATING ROOM FOR IMPLANTATION OF SCREWS, LOCKING CAPS AND RODS ON AN UNK DATE. PT RETURNED TO OPERATING ROOM AGAIN FOR EXPLANT RODS, SCREWS AND LOCKING CAPS AND REVISED TO TWO LEVELS WITH XLIF AND FOUR LEVELS WITH POSTERIOR CONSTRUCT WITH SCREWS AND RODS ON (B)(6)2010. PRODISC-L WAS NOT EXPLANTED. REASON FOR MULTIPLE REVISIONS IS UNK AT THIS TIME. THIS IS THE 2ND OF 13 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-L INFERIOR PLATE PRODISC-L INFERIOR PLATE MJO SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS| SUPERIOR PLATE| LOCKING CAPS| N-HANCE RODS| POLYETHYLENE INLAY