BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 125

    MDR report key: 11647516 · Received April 12, 2021

    Report

    Report Number
    3013461531-2021-00015
    Event Type
    Injury
    Date Received
    April 12, 2021
    Report Date
    July 11, 2021
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    UDI-DI
    07290014993068
    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. SURGEON INFORMATION AND X-RAY ANALYSIS: THE SURGEON RAISED THE OPTION THAT THE SYSTEM FUNCTIONS BETTER WITHOUT THE EXTENDER COMPONENT. X-RAY MEASUREMENT DONE BY THE COMPANY DID NOT INDICATE OF A CHANGE IN POSTER OR DEFORMITY SIZE BETWEEN THE 6M AND 20 MONTHS FOLLOW UP X-RAY. RISK ASSESSMENT: THE COMPANY CLINICAL EVALUATION REPORT (CER DMS -727 REV T) INDICATED A SUPERIOR PERFORMANCE OF THE MID-C SYSTEM WITH THE EXTENDER COMPONENT COMPARED TO WITHOUT IT. IN ADDITION, NO NEW RISKS OR INCREASE IN THE TREND OF KNOWN RISKS WAS IDENTIFIED WHEN USING THE EXTENDER. THE COMPANY IS MONITORING THE PERFORMANCE AND SAFETY OF THE MID-C SYSTEM CONTINUOUSLY.

    Description of Event or Problem · 1

    THE SURGEON SENT THE PATIENT A 20-MONTH FOLLOW-UP X-RAY. IN HIS EMAIL, HE MADE STATED HIS OPINION " I BELIEVE THAT EXTENSOR MAKES A SECONDARY CONTROLATERAL CURVE. MAYBE I PREFER THE APIFIX SYSTEM WITHOUT EXTENSOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545714 MID-C 125 POSTERIOR RATCHETING ROD SYSTEM, QGP APIFIX LTD AF125 AF 03-01-19 07290014993068

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention