BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALEUTIAN INTERBODY SYSTEM

    MDR report key: 8045728 · Received November 7, 2018

    Report

    Report Number
    3004774118-2018-00160
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 17, 2018
    Report Date
    October 17, 2018
    Manufacturer
    K2M. INC
    Product Code
    LXH
    PMA / PMN Number
    K160547
    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 PART WAS NOT AVAILABLE FOR INVESTIGATION; THEREFORE, WE COULD NOT CONCLUDE THE PRECISE CIRCUMSTANCES OF THIS FAILURE.

    Description of Event or Problem · 0

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A INSERTER TIP BROKE DURING IMPACTION. THE TIP OF THE INSERTER REMAINS IN THE PATIENT CONFINED TO THE CAGE. SURGERY TOOK PLACE ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION YET. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A INSERTER TIP BROKE DURING IMPACTION. THE TIP OF THE INSERTER REMAINS IN THE PATIENT CONFINED TO THE CAGE. SURGERY TOOK PLACE ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887633 ALEUTIAN INTERBODY SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH K2M. INC DLDJ-006

    Patients

    Seq Age Sex Outcome Treatment
    1