BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MID-C 125

    MDR report key: 14839901 · Received June 28, 2022

    Report

    Report Number
    3013461531-2022-00022
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 2, 2022
    Report Date
    May 29, 2023
    Manufacturer
    APIFIX LTD.
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTION PROCESS ANALYSIS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO SPECIFICATION. USER (SURGEON AND PATIENT) INFORMATION ANALYSIS: PATIENT NO. (B)(6)- DOB (B)(6) 2006) WAS OPERATED ON (B)(6) 2018. ON (B)(6) 2022, APIFIX WAS NOTIFIED THAT ON (B)(6), DR. (B)(6) WILL PERFORM A REVISION CASE ON PATIENT #(B)(6) DUE TO IMPLANT BREAKAGE - END OF WAY. THE PATIENT IS HAPPY WITH THE CURVE CORRECTION.  DESIGN : THE DESIGN OF THE MID-C SYSTEM IS AIMING TO TAKE MAINLY AXIAL FORCES, RESULTING FROM THE LOAD GENERATED BY THE DISTRACTION OF THE CURVE AND THE RELEVANT BODY WEIGHT.  THE DEVICE WAS TESTED IN AN AXIAL DIRECTION AND WAS FOUND TO BE ABLE TO HOLD 700N LOAD FOR 10 MILLION CYCLES OF AXIAL LOAD. THE COMPANY INVESTIGATION INDICATED THAT IMPLANT BREAKAGE CAN RESULT FROM TRAUMA, PRACTICING SEVERE SPORTS, DEVELOPMENT OF HYPER-KYPHOSIS, INSERTING THE PEDICLE SCREWS IN A WRONG TRAJECTORY, NOT WORKING ACCORDING TO THE SURGICAL TECHNIQUE, AND MOST COMMONLY FROM THE IMPLANT REACHING ITS END OF THE WAY. BREAKAGES WERE EVIDENT IN 3 MAIN REGIONS, THE IMPLANT BASE, THE MAIN ROD, AND THE ROD'S CONNECTION TO THE POLY-AXIAL JOINT. THE MOST COMMON POINT OF FAILURE WAS THE IMPLANT ROD IN IMPLANTS REACHING THEIR MAXIMAL ELONGATION. RISK ASSESSMENT: REOPERATION EVENTS ARE A KNOWN RISK THAT WAS ASSESSED AND RECORDED BY THE PRODUCT RISK MANAGEMENT FILE. THE RISK OF BROKEN ROD HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE THE CURRENT IMPLANT BREAKAGE RATE DUE TO ANY REASON IS IN LINE WITH THE RATE REPORTED IN THE LITERATURE FOR THIS TYPE OF COMPLICATION AS DESCRIBED IN THE COMPANY'S CER (CLINICAL EVALUATION REPORT). THE RISK HAS BEEN QUANTIFIED, CHARACTERIZED, AND DOCUMENTED AS ACCEPTABLE WITHIN A FULL RISK ASSESSMENT APIFIX IS CLOSING THIS COMPLAINT, BUT WILL CONTINUE TO MONITOR THIS 'FAILURE MODE'; COMPLAINT TRENDING WILL CONTINUE TO MONITOR PER POST MARKETING SURVEILLANCE PROCEDURE (DMS-906). IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, THE COMPLAINT FILE WILL BE REOPENED AND A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    RETURN ANALYSIS: UPON RECEIVING THE EXPLANTED DEVICES AT ORTHOPEDIATRICS IN WARSAW, IN, THE DEVICES WERE CLEANED AND STERILIZED. THE DEVICES WERE PHOTOGRAPHED AND ANALYZED. THE FRACTURE WAS NOTED AT THE MID-POINT OF THE POLE. IT APPEARS THAT THE DEVICE WAS LEFT IMPLANTED FOR SOME PERIOD OF TIME POST FRACTURE, AS THE FRACTURE PLAN IS WORE SMOOTH, THERE WAS DEFORMATION OF THE MATERIAL AROUND THE FRACTURE PLAIN, AND THERE WAS WEAR ON THE SIDE OF THE POLE. BECAUSE IT WAS WORE SMOOTH THE FAILURE MODE CAUSING THE FRACTURE CANNOT BE DETERMINED. WEAR WAS ALSO NOTED ON THE SPHERICAL RINGS AND PHOTOGRAPHED FOR REFERENCE.

    Description of Event or Problem · 0

    PATIENT NO.(B)(6) DOB (B)(6) 2006) WAS OPERATED ON (B)(6) 2018. ON (B)(6) 2022, APIFIX WAS NOTIFIED THAT ON (B)(6) 2022, DR. (B)(6) WILL DO A REVISION CASE ON PATIENT #205 DUE TO IMPLANT BREAKAGE - END OF WAY. THE PATIENT IS HAPPY WITH THE CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017601 MID-C 125 POSTERIOR RATCHETING ROD SYSTEM QGP APIFIX LTD. MID-C 125 AF 10-01-17

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female