BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHESAPEAKE SPINAL SYSTEM

    MDR report key: 7270851 · Received February 14, 2018

    Report

    Report Number
    3004774118-2018-00005
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    January 22, 2018
    Report Date
    January 22, 2018
    Manufacturer
    K2M INC.
    Product Code
    MAX
    PMA / PMN Number
    K092211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 SCREW REMAINS IN THE PATIENT, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED.

    Description of Event or Problem · 0

    ON 01.22.2018 IT WAS REPORTED TO K2M, INC. THAT A SCREW BROKE SIX MONTHS POST-OPERATIVELY. PATIENT WILL BE REVISED ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS NOT 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) 2018 IT WAS REPORTED TO K2M, INC. THAT A SCREW BROKE SIX MONTHS POST-OPERATIVELY. REVISION SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112936 CHESAPEAKE SPINAL SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX K2M INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention