BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDC IMPLANT

    MDR report key: 2983206 · Received February 28, 2013

    Report

    Report Number
    2530088-2013-00238
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    January 30, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO PART OR LOT NUMBERS WERE PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A PRODISC-C AT C5-C6, ON AN UNKNOWN DATE FOR RADICULAR SYMPTOMS. ON (B)(6) 2013, THE PATIENT WAS RETURNED TO THE OR FOR REMOVAL OF THE PRODISC-C IMPLANT AND REVISED TO AN ACDF DUE TO PERSISTENT SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88311 PDC IMPLANT MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention