BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDC IMPLANT

    MDR report key: 3042834 · Received April 9, 2013

    Report

    Report Number
    2530088-2013-00528
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    December 9, 2008
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT IS REPORTED PATIENT DIAGNOSED WITH HERNIATED NUCLEUS PULPOSUS, OSTEOPHYTES AND LOSS OF DISC HEIGHT C6-C7 ON (B)(6) 2004. PATIENT WAS IMPLANTED WITH PRODISC-C MODEL L-5 ON (B)(6) 2004. DURING THE PATIENT'S 4TH YEAR FOLLOW UP VISIT ON AN UNKNOWN DATE IN 2008, IT WAS NOTED THAT THE PATIENT'S DISC LEVEL WAS FUSED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145869 PDC IMPLANT MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1