BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESA SPINAL SYSTEM

    MDR report key: 8471567 · Received April 1, 2019

    Report

    Report Number
    3004774118-2019-00029
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 5, 2019
    Manufacturer
    K2M. INC
    Product Code
    MNI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF FURTHER DETAIL IT WAS DETERMINED THAT THE REVISION SURGERY WAS PLANNED AND WAS NOT DUE TO A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    ON (B)(6) 2019 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH THREE SCREW INSERTERS AND SCREW REMOVAL TOOL BROKE AT THE TIP INTRA-OPERATIVELY. IT IS UNKNOWN IF REVISION WAS RELATED TO A DEVICE PROBLEM. (RELATED TO 3004774118-2019-00037)

    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) 2019 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH THREE SCREW INSERTERS AND SCREW REMOVAL TOOL BROKE AT THE TIP INTRAOPERATIVELY. IT IS UNKNOWN IF THE PATIENT WAS REVISED. (RELATED TO 3004774118-2019-00037)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261959 MESA SPINAL SYSTEM ORTHOSIS, SPINAL PEDICAL FIXATION, MNI K2M. INC BXBW014,AHAG005, ANTJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 801-90001 LOT CKVT| 801-9001 LOT CKVT