BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L REVISIONS

    MDR report key: 2901380 · Received January 8, 2013

    Report

    Report Number
    2520274-2013-00167
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    February 8, 2010
    Manufacturer
    SYNTHES
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. EXACT IMPLANT DATE NOT KNOWN. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) COMPLAINT HANDLING UNIT REPORTED THE PATIENT HAD PAIN AFTER SURGERY. NO MATERIAL WAS RECEIVED FOR INVESTIGATION. THE OPERATION WAS IN 2005 ON THE L5 S1. THE PATIENT WAS SUFFERING FROM LOW BACK PAIN AND SEVERE RADICULOPATHY ON BOTH SIDES SINCE THE SURGERY. THE PATIENT WAS REOPERATED IN (B)(6) 2010. THE PRODISC-L IMPLANT WAS NOT TOUCHED, FUSION ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10162 PRODISC-L REVISIONS PRODISC-L REVISIONS MJO SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention