BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODISC-L SUPERIOR PLATE

    MDR report key: 2142365 · Received June 21, 2011

    Report

    Report Number
    2520274-2011-00191
    Event Type
    Injury
    Date Received
    June 21, 2011
    Report Date
    June 6, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. DEVICE NOT EXPLANTED. UNABLE TO PROVIDE THE MFR, PMA/510K NUMBER AND/OR THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PT REPORTED, SHE WAS IN AN IDE STUDY AND WAS IMPLANTED WITH PRODISC-L L5 - S1 APPROX ON 2003. PT RETURNED TO A DIFFERENT SURGEON AND AN X-RAY SHOWED A COLLAPSE OF THE PRODISC-L. SURGEON NOTED PT NEEDS REVISION SURGERY. THIS IS ONE OF THREE REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI