BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 125

    MDR report key: 11612256 · Received April 5, 2021

    Report

    Report Number
    3013461531-2021-00013
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    March 6, 2021
    Report Date
    April 4, 2021
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    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 DATA ANALYSIS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO APIFIX SPECIFICATIONS. USER (SURGEON) INFORMATION ANALYSIS: THE X-RAY DEMONSTRATES EXTENDER MISALIGNMENT WITH AN ANGLE OVER 15 DEGREES, THAT WAS PRESENT DURING SURGERY AND INCREASED POST-OP . THE EXTENDER DEGREE INCREASE SINCE THE UPPER SCREWS USED WAS SMALL/SHORT AND COULD NOT HOLD THE DESIRED EXTENDER ANGLE. PATIENT REOPERATION FINDING: THE SURGEON PERFORMED REVISION SURGERY ON (B)(6) 2021 WHERE BIGGER/LONGER SCREWS WERE PLACED AND THE EXTENDER ANGLE WAS CORRECTED. RISK ASSESSMENT: AT THE TIME OF THIS REPORT (MARCH 8, 2021), THE COMPANY'S INCIDENT RATE OF EXTENDER MISALIGNMENT DUE TO WRONG SCREW SIZE SELECTION IS 0.2%. THE RISK OF "EXTENDER AND MID-C SYSTEM NOT PROPERLY ALIGNED" HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE (DMS#777 REV Q1 HAZARD ID 22.8). THE RISK OF "MISUSE- WRONG SELECTION OF THE SIZE OF SCREWS "HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE (DMS#777 REV Q1 HAZARD ID 1.28).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE PATIENT HAD REVISION SURGERY TO CORRECT THE EXTENDER ANGEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512309 MID-C 125 POSTERIOR RATCHETING ROD SYSTEM QGP APIFIX LTD MID-C 125 AF 07-036-20

    Patients

    Seq Age Sex Outcome Treatment
    1