BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 125

    MDR report key: 10498627 · Received September 7, 2020

    Report

    Report Number
    3013461531-2020-00007
    Event Type
    Injury
    Date Received
    September 7, 2020
    Date of Event
    August 6, 2020
    Report Date
    September 2, 2020
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    UDI-DI
    07290014993068
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO APIFIX SPECIFICATIONS. THE X-RAY DEMONSTRATES THAT THE SYSTEM REACHED ITS MAXIMAL ELONGATION, WHICH IS THE WEAKEST POINT OF THE ROD. THUS, PRESSURE 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. AT THE TIME OF THIS REPORT (AUG 2020), THE COMPANY'S INCIDENT RATE DUE TO IMPLANT BREAKAGE AT MAXIMAL ELONGATION IS 0.93% AND THE OVERALL FOR THIS CATEGORY IS 6.21%, WHICH IS WELL WITHIN THE RATE REPORTED IN THE LITERATURE FOR THIS CATEGORY ( 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). BESIDES, THE COMPANY HAS IMPLEMENTED CORRECTIVE ACTION RESULTING IN AN UPDATED DESIGN OF THE MID-C 125 WITH ELONGATION OF 50 MM, HAVING LONGER OVERLAP BETWEEN POLE AND BASE WHICH MITIGATE AGAINST CASES OF MAXIMAL ELONGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2020 THE PATIENT HEARD AND FELT A "SNAP" IN HER BACK WHILE SITTING DOWN., THE X-RAY ON (B)(6) 2020, DEMONSTRATED ON IMPLANT BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964043 MID-C 125 POSTERIOR RATCHETING ROD SYSTEM,, QGP APIFIX LTD MID-C 125 AF 11-05-17 07290014993068

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention