BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA TI POLY SCREW ASSY 6.5 MM X 45 MM

    MDR report key: 4260736 · Received November 14, 2014

    Report

    Report Number
    2184052-2014-00189
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING AN DIS 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 DURING SURGERY AFTER THE USE OF THE PERSUADER A SCREW DISASSEMBLED. THE SCREW WAS THEN REPLACED WITH A DIFFERENT SCREW. IT WAS REPORTED BY THE USER FACILITY THAT IMPACT TO PATIENT WAS AN ADDITIONAL 350 ML OF BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738805 SEQUOIA TI POLY SCREW ASSY 6.5 MM X 45 MM SEQUOIA TI POLY SCREW ASSY 6.5 MM X 45 MM NKB ZIMMER SPINE, INC. 3306-6545 77AS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention