BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM

    MDR report key: 20394985 · Received October 8, 2024

    Report

    Report Number
    3013461531-2024-00044
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    September 7, 2024
    Report Date
    January 30, 2025
    Manufacturer
    APIFIX LTD.
    Product Code
    QGP
    UDI-DI
    07290018128046
    PMA / PMN Number
    H170001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: BRAND NAME [D1] OF THE DEVICE WAS INCORRECTLY SUBMITTED IN THE INITIAL REPORT; BRAND NAME HAS BEEN CORRECTED IN THIS REPORT TO 'MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM'. ADDITIONAL INFORMATION / DEVICE EVALUATION: THE EXPLANTED DEVICE WAS RETURNED, AND WAS SUBJECTED TO CLEANING, STEAM STERILIZING, AND ENGINEERING EVALUATION. THE DEVICE WAS OBVIOUSLY FRACTURED IN THE BASE COMPONENT, AROUND THE SPHERICAL RING HOUSE OF THE BASE. THE EXTENDER WAS REMOVED AND INSPECTED FOR WEAR. NO WEAR WAS FOUND ON THE EXTENDER AND THE SPHERICAL RINGS. IT IS SUSPECTED THAT THE [PATIENT] KYPHOSIS LEAD TO REPEATED IMPACT LOADING ON THE DEVICE WHICH EVENTUALLY LEAD TO FRACTURE. THERE WERE NO OBVIOUS MANUFACTURING OR DESIGN DEFECTS WHICH CONTRIBUTED TO THE FAILURE. OVER THE YEARS, THE COMPANY ALREADY IMPLEMENTED CORRECTIVE ACTION WITH THE FOLLOWING: ON 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 (APPROVED IN H170001/S002): 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. ECO-46 (APPROVED IN H170001/S002): A TRIAL TOOL ADDED TO THE SURGICAL TOOLS TO AID THE SURGEON IN DETECTING IF ACCESS TISSUE REMAINS BELOW THE IMPLANT. ON MARCH 2020, THE TOPIC OF PRACTICING SEVERE SPORTS ADDED TO THE MID-C TRAINING PRESENTATION. A PRECAUTION ABOUT SEVERE SPORTS WAS INCLUDED IN THE IFU APPROVED IN H170001. ON OCTOBER 2020, 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. ECO-13264 (APPROVED IN H170001/S015): INCREASE STRENGTH THROUGH: DECREASE STRESS CONCENTRATIONS AND INCREASE CROSS SECTIONAL AREA AT CRITICAL REGIONS

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE DEVICE WAS MANUFACTURED AND TESTED ACCORDING TO RELEVANT PROCEDURES,AND SHIPPED ACCORDING TO MANUFACTURER'S SPECIFICATIONS. SURGEON, INFORMATION ANALYSIS: ON 09-SEP-2024 APIFIX WAS NOTIFIED THAT PATIENT#: (B)(6) (PAS#: 091-A060) UNDERWENT A REVISION SURGERY ON THAT DAY DUE TO A BROKEN ROD. ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED A "POP" SENSATION WHILE STRETCHING AND A SUDDEN ONSET OF PAIN BEGAN IN HER BACK ON (B)(6) 2024. PATIENT WENT TO THE EMERGENCY DEPARTMENT AROUND THEIR COLLEGE AND THEN WERE SENT TO DAYTON CHILDREN'S HOSPITAL ON (B)(6) 2024. PATIENT UNDERWENT REVISION SURGERY TO REMOVE AND REPLACE THE BROKEN IMPLANT. ON (B)(6) 2024. RISK ASSESSMENT: REOPERATION EVENTS ARE A KNOWN RISK THAT WAS ASSESSED AND RECORDED BY THE PRODUCT RISK ASSESSMENT. IMPLANT BREAKAGE IS ADDRESSED IN THE IFU AS POTENTIAL RISKS ASSOCIATED WITH THE MID-C SYSTEM AND SPINAL SURGERY GENERALLY. THE RISK OF BROKEN ROD - IMPLANT BREAKAGE HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE. THE RISK HAS BEEN QUANTIFIED, CHARACTERIZED, AND DOCUMENTED AS ACCEPTABLE WITHIN FULL RISK ASSESSMENT. THE EXPLANTED DEVICE HAS BEEN RETURNED TO MANUFACTURER. A FAILURE ANALYSIS WILL BE CONDUCTED. ONCE ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 09-SEP-2024, APIFIX WAS NOTIFIED THAT PATIENT#: (B)(6) (PAS#: 091-A060) UNDERWENT A REVISION SURGERY ON THAT DAY DUE TO A BROKEN ROD. ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED A "POP" SENSATION WHILE STRETCHING AND A SUDDEN ONSET OF PAIN BEGAN IN HER BACK ON (B)(6) 2024. PATIENT WENT TO THE EMERGENCY DEPARTMENT AROUND THEIR COLLEGE AND THEN WERE SENT TO (B)(6) HOSPITAL ON (B)(6) 2024. PATIENT UNDERWENT REVISION SURGERY TO REMOVE AND REPLACE THE BROKEN IMPLANT. ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2544184 MINIMALLY INVASIVE DEFORMITY CORRECTION (MID-C) SYSTEM POSTERIOR RATCHETING ROD SYSTEM QGP APIFIX LTD. MID-C 125 AF-09-092-21 07290018128046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female