BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C IMPLANT MEDIUM

    MDR report key: 2120395 · Received June 3, 2011

    Report

    Report Number
    2530088-2011-00153
    Event Type
    Injury
    Date Received
    June 3, 2011
    Report Date
    May 24, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    MJO
    PMA / PMN Number
    P070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. EXPLANT SCHEDULED FOR (B)(4), 2011. UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PATIENT STATUS POST PRODISC-C IMPLANTATION LEVEL C4-5 RETURNED TO SURGEON FOR FOLLOW UP VISIT. AN X-RAY SHOWED THE SUPERIOR ENDPLATE HAS MOVED A SMALL BIT ANTERIORLY. SURGEON NOTED PATIENT HAS ARTHRODESIS IN THE SPINE AND THERE IS NOT GOOD ADHERENCE TO THE ENDPLATE. SURGEON SCHEDULED REVISION FOR (B)(6), 2011, PATIENT WILL BE REVISED TO FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODISC-C IMPLANT MEDIUM PRODISC-C IMPLANT MJO SYNTHES (USA) NA 6342313

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Female Required Intervention