BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 2982838 · Received February 28, 2013

    Report

    Report Number
    2520274-2013-01224
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    June 16, 2011
    Manufacturer
    SYNTHES
    Product Code
    JDN
    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, SCREW WAS BROKEN HOWEVER, THEY ARE NOT SURE IF THEY ARE N-SPINE OR PANGEA SCREWS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86061 SCREW JDN SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1