BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD

    MDR report key: 2981320 · Received February 27, 2013

    Report

    Report Number
    2520274-2013-01207
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    July 13, 2011
    Manufacturer
    SYNTHES
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO HAD A 4 LEVEL FUSION WITH N SPINE ABOVE THE ROD BROKE. WE THOUGHT THAT THE FUSION SEGMENT BELOW WAS PROBABLY TOO LONG, L2-S1, AND THAT THE DYNAMIC LEVEL FAILED FOR THAT REASON. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84017 ROD JDN SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1