BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALEUTIAN INTERBODY SYSTEM

    MDR report key: 8139273 · Received December 6, 2018

    Report

    Report Number
    3004774118-2018-00175
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 9, 2018
    Report Date
    November 15, 2018
    Manufacturer
    K2M. INC
    Product Code
    MAX
    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 FUNCTIONALLY INSPECTED. UPON REVIEW OF THE PART, IT WAS OBSERVED THAT THE SHEAR FACE WAS COARSE AND RAISED, WHICH IS CONSISTENT WITH THE EFFECTS OF BRITTLE FRACTURE AT THE EVENT SITE.

    Description of Event or Problem · 0

    ON 11.15.2018 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH THE TIP OF THE SHAFT WAS BROKEN. THE TIP OF THE SHAFT REMAINS IN THE PATIENT.

    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 THE TIP OF THE SHAFT WAS BROKEN. THE TIP OF THE SHAFT REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978368 ALEUTIAN INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT LUMBAR MAX K2M. INC CTHH

    Patients

    Seq Age Sex Outcome Treatment
    1