BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVEREST® SPINAL SYSTEM

    MDR report key: 8371968 · Received February 26, 2019

    Report

    Report Number
    3004774118-2019-00013
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    February 5, 2019
    Report Date
    July 18, 2019
    Manufacturer
    K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION
    Product Code
    NKB
    PMA / PMN Number
    K133944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. IT WAS DETERMINED THAT THE POLYAXIAL SCREW WAS A CONCOMITANT DEVICE AND DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2019 IT WAS REPORTED TO K2M, INC. THAT A SET SCREW BACKED OUT, LOOSENED OR DISENGAGED APPROXIMATELY 24 MONTHS POST-OPERATIVELY. PATIENT WAS REVISED ON (B)(6) 2019. (RELATED TO 3004774118-2019-00014)

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS BEEN RETURNED FOR EVALUATION. 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 POLYAXIAL AND SET SCREW BACKED-OUT, LOOSENED OR DISENGAGED APPROXIMATELY 24 MONTHS POST-OPERATIVELY. PATIENT WAS REVISED ON (B)(6) 2019. (RELATED TO 3004774118-2019-00014).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163117 EVEREST® SPINAL SYSTEM THOROCOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION FNYJ

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 2901-10001 LOT FGGV| 2901-10001 LOT FGGV