BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUKON OCT SPINAL SYSTEM

    MDR report key: 7365048 · Received March 23, 2018

    Report

    Report Number
    3004774118-2018-00031
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    February 27, 2018
    Report Date
    May 1, 2019
    Manufacturer
    K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE INSTRUMENT WAS RETURNED FROM THE FIELD. THE HANDLE WAS DESIGNED AND MANUFACTURED WITH AN AO CONNECTION. THE TORQUE LIMITING SHAFT, WHICH IS INDICATED TO MATE WITH THE HANDLE, WAS DESIGNED WITH A HEXAGONAL CONNECTION. THESE CONNECTOR STYLES ARE NOT CROSS-COMPATIBLE.

    Description of Event or Problem · 0

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH AN INCORRECT INSTRUMENT WAS USED TO TIGHTEN THE SET SCREWS.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED AS THE LOT NUMBER HAS NOT BEEN IDENTIFIED/CONFIRMED IN THIS CASE. SINCE THE SUBJECT DEVICE WAS NOT RETURNED, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH AN INCORRECT INSTRUMENT WAS USED TO TIGHTEN THE SET SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209575 YUKON OCT SPINAL SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7601-10001 LOT GJFU| 7601-90092 LOT UNKNOWN