BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALEUTIAN® INTERBODY SYSTEMS

    MDR report key: 8031395 · Received November 1, 2018

    Report

    Report Number
    3004774118-2018-00155
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 11, 2018
    Report Date
    October 11, 2018
    Manufacturer
    K2M. INC
    Product Code
    LXH
    PMA / PMN Number
    K150481
    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, VISUALLY AND MICROSCOPICALLY INSPECTED. THE DISTAL TIP OF THE INSTRUMENT WAS BROKEN AT THE THREADED FEATURE. ANALYSIS OF THE FRACTURE FACE INDICATES THAT THE FAILURE LIKELY OCCURRED IN TORSION.

    Description of Event or Problem · 0

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT DURING SURGERY A TIP FROM A STRAIGHT INSERTER BROKE AND REMAINS IN THE PATIENT CONFINED TO THE CAGE. THERE IS NO SCHEDULED REVISION AT THIS TIME.

    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 DURING SURGERY A TIP FROM A STRAIGHT INSERTER BROKE AND REMAINS IN THE PATIENT CONFINED TO THE CAGE. THERE IS NO SCHEDULED REVISION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869207 ALEUTIAN® INTERBODY SYSTEMS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH K2M. INC EXBX

    Patients

    Seq Age Sex Outcome Treatment
    1