BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNESYS DTL SPACER CUTTER

    MDR report key: 5087052 · Received September 18, 2015

    Report

    Report Number
    2184052-2015-00093
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Report Date
    September 3, 2015
    Manufacturer
    ZIMMER SPINE
    Product Code
    NQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. REVIEW OF INFORMATION PROVIDED AND ANALYSIS OF THE RETURNED DEVICE CONCLUDED THAT THERE IS NO EVIDENCE OF A PRODUCT DEFECT. MANUFACTURING RECORDS REVIEWED INDICATED NO DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE INFORMATION CONTAINED HEREIN IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO A DEATH OR INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DYNESYS SPACER CUTTER WAS FOUND DURING KIT INSPECTION TO BE SEIZED AND STIFF AND HARD TO OPERATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620600 DYNESYS DTL SPACER CUTTER DYNESYS DTL SPACER CUTTER NQP ZIMMER SPINE 07.01284.001 60970745A

    Patients

    Seq Age Sex Outcome Treatment
    1