BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVEREST SPINAL SYSTEM

    MDR report key: 7572690 · Received June 6, 2018

    Report

    Report Number
    3004774118-2018-00073
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    May 14, 2018
    Report Date
    May 11, 2018
    Manufacturer
    K2M INC.
    Product Code
    NKB
    PMA / PMN Number
    K133944
    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. INVESTIGATION ANALYSIS INDICATED THAT ALL AVAILABLE SET SCREWS WERE FULLY ENGAGED ON THE RODS, WHILE SOME WEAR PATTERNS WERE ALSO CONSISTENT WITH DYNAMIC MOTION WITHIN THE CONSTRUCT. IT COULD NOT BE DETERMINED IF THIS DYNAMIC MOTION WAS A CONTRIBUTOR TO, OR RESULT OF, THE DISASSOCIATION. IT WAS REPORTED THAT THE PATIENT WAS NON-AMBULATORY, WHICH COMBINED WITH NON-FUSION AT THE UN-INSTRUMENTED LEVELS, MAY HAVE CONTRIBUTED TO UNANTICIPATED LOADING OF THE CONSTRUCT LEADING TO FAILURE. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE ASCERTAINED.

    Description of Event or Problem · 1

    ON 05.11.2018 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A BACKED-OUT SET SCREW AND OFFSET CONNECTOR AND A BENT SIDE CONNECTOR APPROXIMATELY A MONTH POST-OPERATIVELY. AS A RESULT, THE PATIENT WAS REVISED ON (B)(6) 2018. (RELATED TO 3004774118-2018-00088 AND 3004774118-2018-00089)

    Description of Event or Problem · 1

    ON (B)(4) 2018 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A BACKED-OUT SET SCREW AND OFFSET CONNECTOR AND A BENT SIDE CONNECTOR APPROXIMATELY A MONTH POST-OPERATIVELY. AS A RESULT, THE PATIENT WAS REVISED ON (B)(6) 2018. (RELATED TO 3004774118-2018-00088 AND 3004774118-2018-00089).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416714 EVEREST SPINAL SYSTEM PEDICLE SCREW SPINAL FIXATION NKB K2M INC. FTFA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 101-655100 LOT FFBE| 101-655100 LOT FKKX| 2901-75535G LOT FWPD| 2901-86055YA LOT GHKM| 2901-86055YA LOT GHLC