BEUDAMED
    FDA Recall Terminated

    GIZA Vertebral Body Replacement

    Recall: Z-2072-2017 · Initiated March 17, 2017

    Recall

    Recall Number
    Z-2072-2017
    Event Number
    76852
    Firm
    Eden Spine Europe SA rue du
    FEI Number
    3008844415
    Product Code
    MQP
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    March 17, 2017
    Terminated
    January 6, 2020
    Address
    31 Decembre 41 Geneva Switzerland

    Description

    GIZA Vertebral Body Replacement

    Reason

    Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.

    Action

    A correction letter to the users was sent on March 28, 2017 Stating the following: Eden Spine Europe has become aware of extremely rare incidents of disassembly of Giza devices, which is distributed by Stryker Spine in the USA. These incidents have occurred in limited situations when a surgeon has needed to unscrew the device in order to readjust the distraction. To mitigate this risk, a more precise description of the unlocking procedure in the Giza Surgical Technique was added to prevent surgeons from fully unscrewing the locking screw. POTENTIAL HAZARD In the unlikely event the Giza device was to disassemble, the potential hazard is that the surgeon may decide either to reassemble the device or change the implant to a new device. This could potentially lead to a short surgical time delay of 2 to 10 minutes. RISK MITIGATIONS Eden Spine Europe and Stryker have added the following information in the Giza Surgical Technique to mitigate the risk of disassembly of the device: Note: If adjustment is needed, the implant locking mechanism must be unscrewed 3.5 to 4 rotations from the tightened position, to free the superior cylinder from the inferior one. No more than 4 counterclockwise rotations should be applied to the locking screw, as doing so could potentially lead to disassembly of the implant's locking mechanism. The GIZATM Vertebral Body Replacement surgical technique is available on Stryke Spine's website. ACKNOWLEDGEMENT OF THIS NOTICE Please acknowledge within 5 days of receipt of this notice: - Fill out and send the following online for: https://fr.surveymonkey.com/r/5XYT3ZQ - Or Send an Email to the following address: [email protected] stating that this notice was received. For any questions you may contact: Christophe Zuanon, Regulatory Affairs & Quality Assurance Manager [email protected] Manager, [email protected]

    Distribution

    AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY

    Quantity

    1,839