BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 105L

    MDR report key: 11855531 · Received May 20, 2021

    Report

    Report Number
    3013461531-2021-00019
    Event Type
    Injury
    Date Received
    May 20, 2021
    Report Date
    May 19, 2021
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PRODUCTION PROCESS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO APIFIX SPECIFICATIONS. THE FOLLOW-UP X-RAY ANALYSIS: THE PATIENT PARTICIPATES IN CLINICAL STUDY NO (B)(4) OPERATED ON (B)(6) 2019. THE TWO-YEAR FOLLOW-UP X-RAY DEMONSTRATES CURVE PROGRESSION. AS THERE ARE ONLY 3 PATIENTS IN THIS CLINICAL STUDY THE REASON FOR THE CURVE PROGRESSION IS NOT CLEAR. THE USE OF TWO EXTENDERS, AS IN THIS CASE, WAS DONE IN ONE OTHER SITE AND WAS STOPPED, AS IT IS MORE DIFFICULT TO BALANCE THE IMPLANT USING 2 EXTENDERS. THIS MAY BE A CONTRIBUTING REASON IN THIS CASE TOO. RISK ASSESSMENT: THE RISK OF CURVE PROGRESSION IS A KNOWN RISK. THE CURRENT CURVE PROGRESSION COMPLAINT RATE IS (B)(4). THE RATE OF COMPLAINTS IN THE CATEGORY "SERIAL CASTING, DEFORMITY PROGRESSION, CRANKSHAFT/ADDING ON, PROXIMAL/DISTAL JUNCTIONAL KYPHOSIS, RIB PROMINENCE, RESIDUAL RIB DEFORMITY, TRUNK IMBALANCE, THE DISTAL ADDING-ON PHENOMENON" IS 2.5% WHICH IS WELL WITHIN THE LITERATURE REPORTED RATE OF (B)(4) (CER DMS-727 REV T). THE EVENT OF CURVE PROGRESSION IS ADDRESSED IN THE IFU AT SECTION POTENTIAL RISKS ASSOCIATED WITH THE MID-C SYSTEM: IMPLANT MIGRATION, LOOSENING, OR DISLOCATION; FRACTURE OR BREAKAGE OF THE IMPLANT OR PEDICLE SCREWS, INCLUDING FAILURE TO MAINTAIN EXTENSION/CURVE CORRECTION

    Description of Event or Problem · 1

    THE PATIENT PARTICIPATES IN CLINICAL STUDY NO (B)(4) OPERATED ON (B)(6) 2019. APIFIX CLINICAL AFFAIRS REVIEW THE PATIENT 2-YEAR FOLLOW-UP AND NOTED A SIGNIFICANT INCREASE IN THE CURVE SIZE. FOLLOWING THE SURGEON CORRESPONDED SHE PLANS TO REPLACE APIFIX SYSTEM WITH ANOTHER GROWING SYSTEM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752723 MID-C 105L POSTERIOR RATCHETING ROD SYSTEM,, QGP APIFIX LTD AF105L AF-08-01-17

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention