BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 125

    MDR report key: 12072975 · Received June 27, 2021

    Report

    Report Number
    3013461531-2021-00023
    Event Type
    Injury
    Date Received
    June 27, 2021
    Date of Event
    May 31, 2021
    Report Date
    June 27, 2021
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    UDI-DI
    07290014993068
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PRODUCTION PROCESS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO APIFIX SPECIFICATIONS. SURGEON INFORMATION AND X-RAY ANALYSIS: THE PATIENT WAS INITIALLY OPERATED ON (B)(6), 2020, THE POST-OPERATION X-RAY DEMONSTRATES THAT THE SCREW WAS MISPLACED DURING THE INDEX PROCEDURE ON PATIENT COMPLAINT ABOUT PAIN, FOLLOW UP X-RAY ON /JAN/2021 SHOW THAT THE LOWER EXTENDER SCREW WAS OUT OF THE PEDICLE, DUE TO SCREW MISPLACEMENT. PLACING SCREWS CORRECTLY INSIDE THE PEDICLE IS THE SURGEON'S EXPERTISE AND IS NOT RELATED TO THE APIFIX SYSTEM. RISK ASSESSMENT: AT THE TIME OF THIS REPORT (JUN 03, 2021), THE COMPANY'S INCIDENT RATE OF SCREW MISPLACEMENT IS 1.6 % WHICH IS WELL WITHIN THE RATE REPORTED IN THE LITERATURE 13 %(CER 727 REV T). THE RISK OF MISUSE-THE SURGEON DOES NOT FOLLOW THE IFU AND/OR THE SURGICAL TECHNIQUE GUIDE THAT MAY LEAD TO PAIN HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE (DMS#777 REV Q1 HAZARD ID 1.5) THE CURRENT COMPLAINT DOES CHANGE THE RISK PROBABILITY SCORE. EVENT OF PAIN ADDRESSED IN THE IFU WARNINGS AND PRECAUTIONS SECTION: "METALLIC IMPLANTS CAN LOOSEN, FRACTURE, CORRODE, MIGRATE, OR CAUSE PAIN."

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE PATIENT WILL REVISE TO THE NEW APIFIX SYSTEM ON (B)(6) 2021 DUE TO SCREW MISPLACEMENT BASED ON THE FOLLOW-UP X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969779 MID-C 125 POSTERIOR RATCHETING ROD SYSTEM,,, QGP APIFIX LTD MID-C 125 AF 10-01-19 07290014993068

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention