BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOJAVE EXPANDABLE INTERBODY SYSTEM

    MDR report key: 8178294 · Received December 19, 2018

    Report

    Report Number
    3004774118-2018-00184
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 29, 2018
    Report Date
    November 29, 2018
    Manufacturer
    K2M. INC
    Product Code
    MAX
    PMA / PMN Number
    K171097
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. IT WAS REPORTED THAT THERE IS LOOSE MOVEMENT OF THE EXPANDING KNOB IN THE MEDIAL/LATERAL DIRECTIONS. THE SIDEWAYS MOTION OF THE IMPLANT IS NOT INDICATIVE OF AN ADVERSE EVENT. THE LOCKING SCREW WAS PUT INTO PLACE AND THE IMPLANT IS LOCKED INTO PLACE AS INTENDED.

    Description of Event or Problem · 0

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT DURING SURGERY THE EXPANDABLE INTERBODY BROKE INTRA-OPERATIVELY. THE IMPLANT WAS LOCKED INTO PLACE AND RETAINED INSIDE THE PATIENT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. IT WAS REPORTED DURING A SURGERY UTILIZING THE EVEREST PEDICLE SCREW SYSTEM, THE PATIENT EXPERIENCED A CHANGE IN MEDICAL CONDITION. THE HARDWARE APPLICATION WAS STOPPED TO ATTEND TO THE MEDICAL CONDITION. THE HARDWARE APPLICATION WAS NOT COMPLETED. NO ADVERSE EVENTS INVOLVING HARDWARE WERE OBSERVED. AS REPORTED BY THE SURGEON, THIS WAS NOT A HARDWARE RELATED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH AN EXPANDABLE INTERBODY IMPLANT BROKE DURING INSERTION. IT IS UNKNOWN WHETHER THE CLIP OR A PORTION OF THE COMPONENT REMAINS IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A SURGERY UTILIZING THE EVEREST PEDICLE SCREW SYSTEM, THE PATIENT EXPERIENCED A CHANGE IN MEDICAL CONDITION. THE HARDWARE APPLICATION WAS STOPPED TO ATTEND TO THE MEDICAL CONDITION. THE HARDWARE APPLICATION WAS NOT COMPLETED. NO ADVERSE EVENTS INVOLVING HARDWARE WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018228 MOJAVE EXPANDABLE INTERBODY SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX K2M. INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 2901-90042 LOT UNKNOWN| 2901-90043 LOT UNKNOWN| 2911-06545 LOT UNKNOWN