BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVEREST SPINAL SYSTEM

    MDR report key: 7559991 · Received June 1, 2018

    Report

    Report Number
    3004774118-2018-00078
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    April 26, 2018
    Report Date
    May 7, 2018
    Manufacturer
    K2M INC.
    Product Code
    NKB
    PMA / PMN Number
    K151727
    Product Problem
    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 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. 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. SINCE THE SUBJECT DEVICE WAS DISPOSED, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. FURTHER INVESTIGATION REVEALED THAT DIFFICULTY USING THE ROD INSERTER MIGHT HAVE ALSO CAUSED OR CONTRIBUTED IN SURGICAL DELAY.

    Description of Event or Problem · 1

    ON 5.7.2018 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH EXTENDED TABS BROKE INTRA-OPERATIVELY CAUSING SIGNIFICANT DELAY IN SURGERY. SURGERY TOOK PLACE (B)(6) 2018. (RELATED TO 3004774118-2018-00077).

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT THERE WAS A SIGNIFICANT DELAY IN SURGERY DUE TO INTRA-OP EXTENDED TAB BREAKAGE AND DIFFICULTY USING AN INSTRUMENT. SURGERY TOOK PLACE (B)(6) 2018. (RELATED TO 3004774118-2018-00077 AND 3004774118-2018-00096).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403062 EVEREST SPINAL SYSTEM PEDICLE SCREW SPINAL FIXATION NKB K2M INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 5101-90159| 5101-90218| 5101-90219| E5112-06545