BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVEREST ® SPINAL SYSTEM

    MDR report key: 8567613 · Received April 30, 2019

    Report

    Report Number
    3004774118-2019-00047
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    April 8, 2019
    Report Date
    April 30, 2019
    Manufacturer
    K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION
    Product Code
    NKB
    PMA / PMN Number
    K151727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION YET. 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 SURGERY TOOK PLACE IN WHICH A POLYAXIAL SCREW DID NOT PERFORM ACCORDING TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360891 EVEREST ® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1001-E5545 LOT UNKNOWN| 2901-10001 LOT UNKNOWN| F2911-07450 LOT UNKNOWN