BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXLINK

    MDR report key: 3922397 · Received June 3, 2014

    Report

    Report Number
    2184052-2014-00089
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    HWC
    Removal / Correction Number
    1649384-10/16/2009-003R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE DISTAL PRONGS ARE BENT. MANUFACTURING RECORDS REVIEWED INDICATED NO DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS DESIGN RELATED. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEXLINK POLYAXIAL SCREWDRIVER WAS FOUND TO BE WORN DURING INSPECTION. HOWEVER, VISUAL ANALYSIS OF THE RETURNED INSTRUMENT FOUND THAT THE PRONGS WERE BENT. IT IS NOT KNOWN HOW OR WHEN THE DAMAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323182 NEXLINK POLYAXIAL SCREWDRIVER HWC ZIMMER SPINE 781-01 19G

    Patients

    Seq Age Sex Outcome Treatment
    1