BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRUT, LARGE, 08MM

    MDR report key: 3853419 · Received April 4, 2014

    Report

    Report Number
    2184052-2014-00056
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. MANUFACTURING RECORDS REVIEWED INDICATED NO DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT WAS OPERATIONAL CONTEXT AS THE DEVICE PERFORMANCE WAS LIMITED BY PROCEDURAL/ANATOMICAL FACTORS. 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

    SAME CASE AS: 2184052-2014-00059, 2184052-2014-00057, 218052-2014-00058, 2184052-2014-00054, 2184054-2014-00055. IT WAS REPORTED THAT DURING SURGERY THE SURGEON HAD TROUBLE IMPLANTING THE INFIX IMPLANT. THE FIRST SET OF 8MM STRUTS STARTED TO SCISSOR, SO THEY WERE PUT ASIDE AND THE SURGEON LOADED TWO NEW 8MM STRUTS IN THE GUIDES. AFTER TRYING TO LOCK THE CONSTRUCT THE LOCKER DID NOT WORK. THE SURGEON LOOKED AND SAW THE 8MM STRUTS HAD SCISSORED AND DAMAGED THE ENDPLATE. THE SURGEON USED DIFFERENT SIZED STRUTS AND WAS ABLE TO SUCCESSFULLY COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205003 STRUT, LARGE, 08MM STRUT, LARGE, 08MM NKB ZIMMER SPINE 1804-508 75TP

    Patients

    Seq Age Sex Outcome Treatment
    1