BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MID-C 125

    MDR report key: 18984849 · Received March 27, 2024

    Report

    Report Number
    3013461531-2024-00015
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    February 29, 2024
    Report Date
    July 14, 2024
    Manufacturer
    APIFIX LTD.
    Product Code
    QGP
    UDI-DI
    07290018128046
    PMA / PMN Number
    H170001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024 THE PATIENT UNDERWENT REVISION SURGERY DURING WHICH THE MID-C WAS REPLACED WITH A NEW ONE, AND NEW POLYAXIAL SCREWS WERE IMPLANTED AT T5-T6. THE APIFIX SCREW IN T12 REMAINED IMPLANTED AND USED WITH THE CONSTRUCT. RETURN ANALYSIS: THE EXPLANTED DEVICE WAS RETURNED, AND WAS SUBJECTED TO CLEANING, STEAM STERILIZING, AND ENGINEERING EVALUATION. THE DEVICE WAS OBVIOUSLY FRACTURED IN THE POLE COMPONENT AROUND THE MID-POINT OF THE POLE. POST-FRACTURE, THE DEVICE REMAINED IMPLANTED AS THE FRACTURE PLANE, INSIDE OF THE BODY, AND EDGE OF THE BASE AND POLE SHOWED SIGNS OF WEAR. THE FRACTURE PLANE WAS WORN SMOOTH AND THUS FRACTURE MODE IS UNABLE TO BE IDENTIFIED. THE EXTENDER WAS REMOVED, AND THE SPHERICAL RINGS WERE INSPECTED FOR WEAR. WEAR AND DEFORMITY WERE OBSERVED ON THE SPHERICAL RING OF THE BASE. NO WEAR WAS VISIBLY OBSERVED ON THE SPHERICAL RING OF THE POLE. OVER THE YEARS, THE COMPANY ALREADY IMPLEMENTED CORRECTIVE ACTION WITH THE FOLLOWING: ON (B)(6) 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

    PRODUCTION PROCESS ANALYSIS: 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. USER (SURGEON AND PATIENT) INFORMATION ANALYSIS: ON 29-FEB-2024 APIFIX WAS NOTIFIED THAT PATIENT #(B)(6) (INDEX PROCEDURE 04-DEC-2020) IS SCHEDULED FOR REVISION SURGERY OF 05-APR-2024 DUE TO A BROKEN ROD (MALE PORTION OF THE RATCHET MECHANISM). MINIMAL SYMPTOMS. RISK ASSESSMENT: IMPLANT BREAKAGE CAN RESULT FROM TRAUMA, PRACTICING CONTACT OR HIGH DEMAND SPORTS, HYPER-KYPHOSIS, INSERTING THE PEDICLE SCREWS IN A WRONG TRAJECTORY WHICH LOCKS THE POLY-AXIAL JOINTS, NOT WORKING ACCORDING TO THE SURGICAL TECHNIQUE (E.G., MINIMALLY INVASIVE APPROACH AND/OR NOT USING THE TRIAL TOOL PROPERLY). RE-OPERATION EVENTS ARE A KNOWN RISK THAT WAS ASSESSED AND RECORDED BY THE PRODUCT RISK ASSESSMENT. THE RISK OF MECHANICAL FAILURE OF THE MID-C MECHANISM - [IMPLANT BREAKAGE] HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE. THE 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 CLINICAL EVALUATION REPORT. THE EXPLANTED DEVICE IS EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR ANALYSIS AFTER THE REVISION SURGERY. UPON COMPLETION OF THE EVALUATIONS, WHEN ADDITIONAL INFORMATION COMES TO LIGHT, THEN A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2024 APIFIX WAS NOTIFIED THAT PATIENT #446 (INDEX PROCEDURE (B)(6) 2020) IS SCHEDULED FOR REVISION SURGERY OF (B)(6) 2024 DUE TO A BROKEN ROD (MALE PORTION OF THE RATCHET MECHANISM). MINIMAL SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494281 MID-C 125 POSTERIOR RATCHETING ROD SYSTEM QGP APIFIX LTD. MID-C 115 07290018128046

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male