BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PDC IMPLANT

    MDR report key: 2221567 · Received August 18, 2011

    Report

    Report Number
    2530088-2011-00510
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED APPROX EIGHT WEEKS AGO. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    SURGEON REPORTED TO CONSULTANT: PT STATUS POST PRODISC-C IMPLANTATION APPROX EIGHT WEEKS AGO EXPERIENCED A FALL AND FELT A POP IN THE NECK ALONG WITH PAIN. AN X-RAY ON AN UNK DATE SHOWED THE INFERIOR ENDPLATE SUBSIDED INTO THE VERTEBRAL BODY. SURGEON REMOVED THE PLATE ON (B)(6) 2011. UPDATE FROM CONSULTANT: PT WAS REVISED TO FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK - PDC IMPLANT PRODISC-C IMPLANT MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female