BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD

    MDR report key: 2982922 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-01216
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    July 18, 2011
    Manufacturer
    SYNTHES
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THE NSPINE PRODUCT WAS USED WITH BREAKS SEEN IN THE RODS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86910 ROD HSB SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1