BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVEREST SPINAL SYSTEM

    MDR report key: 6963723 · Received October 19, 2017

    Report

    Report Number
    3004774118-2017-00147
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    September 21, 2017
    Report Date
    September 21, 2017
    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 SUBJECT PRODUCT WAS RETURNED FOR EVALUATION BUT EVALUATION IS STILL IN PROGRESS. UPON COMPLETION OF EVALUATION OF THE SUBJECT PART, 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. A REVIEW OF ALL APPLICABLE MATERIAL, INSPECTION, MANUFACTURING, AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTION OF THE PRODUCT(S) USED WAS CONDUCTED. ALL RECORDS REVEALED THAT ALL PRODUCT(S) LOTS WERE MANUFACTURED WITHIN SPECIFICATIONS AND DISTRIBUTED IN ACCORDANCE WITH ALL OPERATING PROCEDURES. DURING REVIEW OF THE RETURNED INSTRUMENT, THE PROXIMAL HEX END OF THE INSTRUMENT WAS OBSERVED TO THREAD FREE OF THE MAIN BODY. THIS HEX END IS PART OF THE MAIN BODY ASSEMBLY AND HELD IN PLACE BY AN INTERNAL SNAP RING. REVIEW OF THE INTERNAL SNAP RING AND MATING OD RING GROOVE UNDER MAGNIFICATION INDICATED SLIGHT WEAR MARKS SUGGESTING AN ELEVATED FORCE MAY HAVE BEEN APPLIED. THE INSTRUMENT FUNCTION IS TO ASSIST REDUCING A ROD INTO A SCREW HEAD USING FORCE. THE FORCE NECESSARY TO REDUCE A ROD CAN VARY FROM DIFFERENT PATIENT SITUATIONS. EXCESSIVE FORCE IS A POSSIBLE CAUSE FOR THE DISASSOCIATION.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A RESCUE TOWER CAME APART RESULTING IN A SIGNIFICANT DELAY OF APPROXIMATELY 30 MINUTES SURGERY TOOK PLACE (B)(6) 2017.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A RESCUE TOWER CAME APART RESULTING IN A SIGNIFICANT DELAY OF APPROXIMATELY 30 MINUTES SURGERY TOOK PLACE (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741020 EVEREST SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM LXH K2M, INC. EATP005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other