BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFERIOR END PLATE MEDIUM-STERILE

    MDR report key: 2962982 · Received February 15, 2013

    Report

    Report Number
    2530088-2013-00161
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. REVIEW OF THE DEVICE HISTORY RECORDS AND THE RAW MATERIAL RECORDS INDICATE THERE WERE NO MANUFACTURING DISCREPANCIES RELEVANT TO THIS COMPLAINT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TWO PRODISC L IMPLANTS ON (B)(6) 2009. SCHEDULED SURGERY TO REMOVE LUMBAR DISCS L4, L5 AND L5, S1 WAS PERFORMED ON (B)(6) 2013 DUE TO UNEXPLAINABLE PATIENT PAIN. ONE LEVEL WAS REMOVED LATERALLY, L4, L5, AND ONE ANTERIORLY, L5, S1. PRIOR TO SURGERY, THE SURGEON DID NOT BELIEVE THAT THE DISCS HAD SHIFTED. HOWEVER, AN X RAY TAKEN ON (B)(6) 2013 REVEALED THE DISCS HAD MIGRATED. IT WAS REPORTED THAT THE SURGERY WENT WELL AND NOTHING WAS WRONG WITH THE IMPLANTS THEMSELVES. THE SURGEON REPLACED THE IMPLANTS WITH PEAK CAGES AND FUSED THE PATIENT FROM THE BACK. THIS IS 5 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68189 INFERIOR END PLATE MEDIUM-STERILE INFERIOR END PLATE MJO SYNTHES BRANDYWINE 5893577

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention