BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESYS

    MDR report key: 2512273 · Received March 28, 2012

    Report

    Report Number
    9613350-2012-00374
    Event Type
    Injury
    Date Received
    March 28, 2012
    Date of Event
    March 16, 2012
    Report Date
    March 16, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. A PRODUCT FAILURE CANNOT BE CONFIRMED. AS STATED IN THE EVENT DETAIL, THE PRODUCT PERFORMED WELL ACCORDING TO THE SURGEON. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE INITIAL SURGERY HAD BEEN PERFORMED IN 2008 BY A DIFFERENT SURGEON. THE PT PRESENTED TO THE NEW SURGEON WITH LEFT SIDED PAIN. X-RAY EXAMINATION SHOWED ADJACENT LEVEL DISEASE. THE SURGEON DECIDED TO REMOVE ALL THE DYNESYS HARDWARE AS THE PT HAD FUSED AND THE INSTRUMENT HAD DONE ITS JOB. A TLIF WAS PERFORMED. THERE WERE NO PRODUCT PERFORMANCE ISSUES WITH THE REMOVED DYNESYS PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNESYS DYNESYS SPINAL SYSTEM NQP ZIMMER, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R