BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OZARK¿ CERVICAL PLATE SYSTEM

    MDR report key: 8382754 · Received March 1, 2019

    Report

    Report Number
    3004774118-2019-00022
    Event Type
    Malfunction
    Date Received
    March 1, 2019
    Date of Event
    February 7, 2019
    Report Date
    September 18, 2019
    Manufacturer
    STRYKER-SPINE
    Product Code
    KWQ
    PMA / PMN Number
    K172104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN OZARK SCREW, PLACED IN THE MOST CAUDAL HOLE LOCATION OF A 3-LEVEL OZARK GUIDE PLATE, MIGRATED ANTERIORLY POST-OPERATIVELY. THE IMPLANT REMAINS IN THE PATIENT AND COULD NOT BE EVALUATED. THE INCIDENT WAS CONFIRMED THROUGH ANALYSIS OF RELEVANT X-RAYS. NO DAMAGE TO THE SCREW COVER AT THE SUBJECT LEVEL WAS VISIBLE.

    Description of Event or Problem · 0

    ON (B)(6) 2019 IT WAS REPORTED TO K2M, INC. THAT TWO SCREWS BACKED-OUT POST-OPERATIVELY.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2019 IT WAS REPORTED TO K2M, INC. THAT TWO SCREWS BACKED OUT. APPROXIMATELY 1-3 MONTHS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174486 OZARK¿ CERVICAL PLATE SYSTEM APPLIANCE FIXATION SPINAL INTERVERTEBRAL BODY KWQ STRYKER-SPINE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1