BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MID-C 125

    MDR report key: 14675427 · Received June 13, 2022

    Report

    Report Number
    3013461531-2022-00020
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 11, 2022
    Report Date
    June 13, 2022
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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 OPERATED ON (B)(6) 2021. ONE WEEK FOLLOWING THE INDEX SURGERY, ON (B)(6) 2021, THE SURGEON INFORMED THE COMPANY'S CMO THAT: "THIS WAS A VERY DIFFICULT CASE. WE DID NOT REALIZE BEFORE SURGERY THAT SHE IS HAVING VERY TINY PEDICLES. WE WERE NOT ABLE TO PLACE A SCREW AT T7. THE SCREW AT T6 IS GOOD (BUT THE PEDICLE IS BROKEN). THE SCREW AT T5 IS IN THE SPINE CANAL BECAUSE WE MISSED THE PATH WHICH IS GOOD. THE SCREW AT L2 IS NOT IN PROPERLY BUT THIS IS THE ONLY WAY TO PUT THE SCREW BECAUSE THERE IS TOO TINY THE PEDICLE. THE PATIENT IS DOING WELL WITHOUT NEUROLOGICAL SYMPTOMS, AND THE FINAL CORRECTION IS VERY GOOD, BUT THE IMPLANT IS FULLY EXPANDED. IT IS PLANNED TO REPLACE THE T5 SCREW AS SOON AS POSSIBLE." ON (B)(6) 2021, THE SURGEON UPDATED THE COMPANY THAT "THE SCREW PLACEMENT WAS VERY DIFFICULT IN THE CASE AND I AM NOT HAPPY. I SUGGESTED REVISING THE SCREWS BUT THE PARENTS PREFER TO WAIT AND SEE. SHE IS DOING WELL UNTIL NOW." ON (B)(6) 2022 THE IMPLANT WAS REMOVED FROM THE PATIENT DUE TO CURVE PROGRESSION, IMPLANT BREAK WAS NOT IDENTIFIED UNTIL REMOVAL OF THE IMPLANT. 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 (SEE DMS#2896 REV A) 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. CAUSE: PER MID-C SURGICAL TECHNIQUE GUIDE (DMS-930), THE SURGICAL PROCESS FOR IMPLANTATION OF THE MID-C SYSTEM IS A POSTERIOR APPROACH WITH A VERTICAL MIDLINE INCISION. SURGEON IN THIS CASE DID NOT PERFORM THE PROCEDURE PER IFU/SURGICAL TECHNIQUE. ADDITIONALLY, SCREWS WERE MISPLACED DURING THE IMPLANT PROCEDURE. CAUSE OF THIS INCIDENT WAS TRACED TO USER; THE PROBLEM IS TRACED TO THE USER NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS. RISK ASSESSMENT: REOPERATION EVENTS ARE A KNOWN RISK THAT WAS ASSESSED AND RECORDED BY THE PRODUCT RISK MANAGEMENT FILE. THE RISK OF CURVE PROGRESSION IS A KNOWN RISK. THE CURRENT CURVE PROGRESSION COMPLAINT RATE IS IN LINE WITH THE RATE REPORTED IN THE LITERATURE FOR THIS TYPE OF COMPLICATION AS DESCRIBED IN THE (CER) CATEGORY "SERIAL CASTING, DEFORMITY PROGRESSION, CRANKSHAFT/ADDING ON, PROXIMAL/DISTAL JUNCTIONAL KYPHOSIS, RIB PROMINENCE, RESIDUAL RIB DEFORMITY, TRUNK IMBALANCE, THE DISTAL ADDING-ON PHENOMENON" THE RISKS HAVE BEEN QUANTIFIED, CHARACTERIZED, AND DOCUMENTED AS ACCEPTABLE WITHIN FULL RISK ASSESSMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A FOREIGN DISTRIBUTOR INFORMED THE COMPANY THAT PATIENT (B)(6) (INDEX SURGERY (B)(6) 2021) HAD THE IMPLANT REMOVED, X-RAYS PROVIDED WITH THE COMPLAINT REPORT SHOW THAT THE PATIENT'S CURVE PROGRESSED TO 53°. THE EXPLANTED IMPLANT IMAGE PROVIDED WITH THE COMPLAINT REPORT SHOWED THAT THE POLE SEPARATED FROM THE BASE. THE IMPLANT WAS REMOVED DUE TO CURVE PROGRESSION, THE BREAK WAS LATER DETERMINED TO ONLY BE IDENTIFIED UPON REMOVAL OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249537 MID-C 125 POSTERIOR RATCHETING ROD SYSTEM QGP APIFIX LTD MID-C 125 AF-07-036-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other