BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MID-C 105L

    MDR report key: 14494753 · Received May 25, 2022

    Report

    Report Number
    3013461531-2022-00019
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Report Date
    May 25, 2022
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO APIFIX SPECIFICATIONS SURGEON X-RAY INFORMATION ANALYSIS: THE PATIENT WAS INITIALLY OPERATED ON (B)(6) 2018. THE 3 YEARS FOLLOW-UP RAISED A SUSPICION OF RATCHET MECHANISM FAILURE/BREAKAGE. THE 3-YEARS X-RAY INDICATED A SMALL FRACTURE FRAGMENT INSIDE THE RATCHET MECHANISM AREA. IN ADDITION, THE X-RAYS INDICATED A RATCHET MALFUNCTION (RESULTING IN A BACKUP OF THE DISTRACTION). RATCHET MALFUNCTION CAN RESULT FROM PHYSICAL TRAUMA, PRACTICING HIGH-DEMAND SPORTS, AND TISSUE GROWTH INSIDE THE RATCHET MECHANISM. RATCHET MALFUNCTION MAY BE A COINCIDENTAL FINDING AND MAY ALSO BE REPORTED TOGETHER WITH PAIN/CURVE PROGRESSION/NOISE. RISK ASSESSMENT: REOPERATION EVENTS ARE A KNOWN RISK THAT WAS ASSESSED AND RECORDED BY THE PRODUCT RISK ASSESSMENT DMS-777 REV Q THIS COMPLAINT DOES NOT CHANGE THE OCCURRENCES RATE. THE TOTAL RATE OF RATCHET MALFUNCTION FOR ANY REASON POSTS ECO- 59 IS 1.23%. THE COMPANY CONTINUES TO MONITOR THE EFFECTIVENESS OF THE MITIGATION.

    Description of Event or Problem · 0

    PATIENT (B)(6) WAS OPERATED ON (B)(6) 2018. THE SURGEON REPORTED THAT THE THREE-YEAR FOLLOW-UP X-RAY INDICATED A FRACTURE OF THE INTERNAL RATCHET MECHANISM. THE PATIENT HAS A LOSS OF CORRECTION AND NO PAIN. NO ACCIDENT OCCURRED. A REVISION IS PLANNED, AND FUSION IS AN OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114822 MID-C 105L POSTERIOR RATCHETING ROD SYSTEM QGP APIFIX LTD MID-C 105L AF 11-04-17

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown