BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNESYS IMPLANT

    MDR report key: 2823681 · Received October 26, 2012

    Report

    Report Number
    9613350-2012-01013
    Event Type
    Other
    Date Received
    October 26, 2012
    Date of Event
    July 11, 2012
    Report Date
    October 3, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCES DOCUMENTS FOR REVIEW, AS THE PT HAS NOT BEEN REVISED TO DATE. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. SHOULD ADD¿L INFO BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    THE PT REPORTED THAT HE/SHE HAD A ¿DYNAMIC STABILIZATION SYSTEM¿ IMPLANTED 5 YEARS AGO (EXACT DATE NOT GIVEN) TO TREAT LOWER BACK PAIN. THE PT ALSO STATED THAT HE/SHE ¿HAS HAD INCREASED PAIN FOR THE LAST 5 YEARS.¿ AT THE TIME OF THIS REPORT IT IS NOT KNOWN IF THE PT IS BEING MONITORED OR IF REVISION SURGERY HAS BEEN PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNESYS IMPLANT DYNESYS IMPLANT NQP ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other