BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDC IMPLANT

    MDR report key: 2914444 · Received January 14, 2013

    Report

    Report Number
    2530088-2013-00045
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    November 8, 2011
    Report Date
    December 17, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A STUDY PATIENT DIAGNOSED WITH CENTRAL HERNIATION WITH RADICULOPATHY WAS IMPLANTED WITH PRODISC-C AT C3-C4 ON (B)(6) 2007. THE PATIENT WAS DIAGNOSED WITH MILD DYSPHAGIA ON (B)(6) 2011 AND WAS TREATED WITH MODIFIED FOOD INTAKE. THE INVESTIGATOR REPORTED THE EVENT WAS DEFINITELY RELATED TO THE TYPE OF SURGERY AND NOT RELATED TO THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20141 PDC IMPLANT PDC IMPLANT MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR