BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 125

    MDR report key: 12954636 · Received December 7, 2021

    Report

    Report Number
    3013461531-2021-00041
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    October 27, 2021
    Report Date
    December 7, 2021
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: .A REVIEW OF DHR OF PRODUCTION PROCESS DEMONSTRATE THAT MID-C SYSTEM WAS MANUFACTURED, TESTED AND RELEASED ACCORDING TO SPECIFICATION. USER (SURGEON AND PATIENT) INFORMATION ANALYSIS: RATCHET MALFUNCTION (RESULTING IN BACKUP OF THE DISTRACTION) 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. FURTHER INVESTIGATION WILL BE DONE ONCE THE IMPLANT WILL BE AVAILABLE. RISK ASSESMENT: 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. RATCHET MALFUNCTION RISK WAS ASSESSED AND FOUNT TO BE ACCEPTABLE IN RISK ASSESSMENT AND CONTROL FOR MID-C SYSTEM' DMS-777 REV Q1 HAZARD ID 1.4 AND 1.6). THE CURRENT INCIDENT RATE OF DEVICE-RELATED ADVERSE EVENTS IS WELL WITHIN THE RATE REPORTED IN THE LITERATURE.

    Description of Event or Problem · 0

    THE PATIENT HAD AN ELECTIVE SURGERY ON (B)(6) 2021, AS THE 125 IMPLANTS REACHED THE END OF ITS WAY. THE SURGEON PLANNED TO MOVE THE SYSTEM ONE LEVEL UP. HOWEVER DURING THE REVISION SURGERY , THE RATCHET MECHANISM FAILED TO ENGAGE, SO THAT THE EXTENSION ACHIEVED COULD NOT BE MAINTAINED. THE IMPLANT WAS REPLACED WITH NEW APIFIX IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855647 MID-C 125 POSTERIOR RATCHETING ROD SYSTEM,, QGP APIFIX LTD MID-C 125 AF 03-01-19

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention