BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAVINE LATERAL ACCESS SYSTEM

    MDR report key: 7344958 · Received March 16, 2018

    Report

    Report Number
    3004774118-2018-00034
    Event Type
    Death
    Date Received
    March 16, 2018
    Date of Event
    February 15, 2018
    Report Date
    February 16, 2018
    Manufacturer
    K2M INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    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. FURTHER INVESTIGATION REVEALED THAT THERE WAS NO ASSOCIATED MALFUNCTION OF THE SUBJECT DEVICE.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. 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 A SURGERY THE PATIENT HAD A SIGNIFICANT CHANGE IN MEDICAL CONDITION INTRA-OPERATIVELY.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT DURING A SURGERY THE PATIENT HAD A SIGNIFICANT CHANGE IN MEDICAL CONDITION INTRA-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189025 RAVINE LATERAL ACCESS SYSTEM INTERVERTEBRAL BODY FUSION DEVICE LXH K2M INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death