BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L OR PRODISC-C

    MDR report key: 1565706 · Received December 23, 2009

    Report

    Report Number
    2520274-2009-00272
    Event Type
    Injury
    Date Received
    December 23, 2009
    Date of Event
    July 8, 2009
    Report Date
    December 2, 2009
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO DETERMINE MFG SITE OR MFG DATE WITHOUT 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 REPORTED PAIN AFTER UNDERGOING A FORAMINOTOMY FROM THE PHYSICIAN WHO IMPLANTED THE PRODISC. LATER DIAGNOSED WITH MECHANICAL PAIN, AND THE DEVICES WERE REMOVED BY A DIFFERENT PHYSICIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention