BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 125

    MDR report key: 11612255 · Received April 5, 2021

    Report

    Report Number
    3013461531-2021-00012
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    March 3, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIRST INVESTIGATION. PRODUCTION PROCESS ANALYSIS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO APIFIX SPECIFICATIONS. USER (SURGEON AND PATIENT) INFORMATION ANALYSIS: THE X-RAY DEMONSTRATES THAT THE SYSTEM REACHED ITS MAXIMAL ELONGATION, WHICH IS THE WEAKEST POINT OF THE ROD. IN THIS POSITION, THE TRANSVERSE PROCESS BELOW THE IMPLANT MAY GENERATE A FORCE ACTING ON THE SYSTEM THAT CAN CAUSE THE ROD BREAKAGE. TO PROTECT AGAINST SUCH FORCE IT IS NECESSARY TO USE THE TRIAL TOOL ACCORDING TO THE DETAILED STEPS AS DESCRIBED IN THE SURGICAL TECHNIQUE GUIDE. THE SURGERY WAS PERFORMED IN A MINIMAL INVASIVE APPROACH (MIS), WHICH MAKES IT QUITE CHALLENGING TO VERIFY THAT THE SURFACE BELOW THE IMPLANT IS SUFFICIENTLY CLEAN FROM ANY SOFT OR HARD TISSUE BEFORE PLACING THE IMPLANT. FOR THIS REASON, THE USE OF MIS TECHNIQUE IS NOT RECOMMENDED BY THE COMPANY AND THE SURGICAL TECHNIQUE INSTRUCTS TO PERFORM THE SURGERY WITH AN OPEN MIDLINE INCISION. CORRECTIVE ACTION: 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. OVER THE YEARS, THE COMPANY ALREADY IMPLEMENTED CORRECTIVE ACTION WITH THE FOLLOWING: ¿IN NOV 2017, ALL SURGEONS RECEIVED A LETTER DETAILING THE IMPORTANCE OF SCREW INSERTION TRAJECTORY. THE TOPIC IS ALSO COVERED IN THE COMPANY'S TRAINING PRESENTATION. ¿ECO-38, REPLACED THE MID-C 125 THAT EXTENDS BY 40 MM TO MID-C 125 THAT EXTENDS BY 50MM ALLOWING MORE OVERLAP BETWEEN THE POLE AND BASE. THE PRESENT SURGERY WAS PERFORMED BEFORE THE IMPLEMENTATION OF THIS CORRECTIVE ACTION USING MID-C 125X40 MM. ¿ECO-46, A TRIAL TOOL WAS ADDED TO THE SURGICAL TOOLS TO AID THE SURGEON IN DETECTING IF ACCESS TISSUE REMAINS BELOW THE IMPLANT. ¿IN MARCH 2020, THE TOPIC OF PRACTICING SEVERE SPORTS WAS ADDED TO THE MID-C TRAINING PRESENTATION. AS PART OF APIFIX COMMITMENT TO CONTINUOUS IMPROVEMENT, CAPA #020-01 WAS INITIATED TO FURTHER INVESTIGATE TO PREVENT AND MINIMIZE THE RATE OF IMPLANT BREAKAGE RATE. RISK ASSESSMENT: THE CURRENT RATE OF IMPLANT FAILURE IS 3.87% WHICH IS IN LINE WITH THE RATE REPORTED IN THE LITERATURE FOR THIS TYPE OF COMPLICATIONS AS DESCRIBED IN THE COMPANY'S CLINICAL EVALUATION REPORT ( 0.2%-15.5%) ( CER DMS-727 REV R) THE RISK OF THE BROKEN ROD HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE (DMS#777 REV Q1 HAZARD ID 1.8).

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE PATIENT HAD A FEW DAYS OF PAIN IN THE RIGHT LOWER BACK, WITH RADIATION TO THE BUTTOCK. WHEN LIED DOWN SHE FELT A "CRACK" IN HER BACK. THE X-RAY ON (B)(6) 2021, DEMONSTRATES THAT THE ROD IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512308 MID-C 125 POSTERIOR RATCHETING ROD SYSTEM QGP APIFIX LTD MID-C 125 AF 11-05-17

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention