BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 105

    MDR report key: 11648187 · Received April 12, 2021

    Report

    Report Number
    3013461531-2021-00017
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 19, 2021
    Report Date
    April 12, 2021
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    FIRST EVALUATION: PRODUCTION PROCESS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO APIFIX SPECIFICATIONS. RISK ASSESSMENT: AT THE TIME OF THIS REPORT (MARCH 29, 2021), THE COMPANY'S INCIDENT RATE OF PAIN (NOT RELATED TO THE SURGICAL PROCEDURE) IS (B)(4) WHICH IS WELL WITHIN THE RATE REPORTED IN THE LITERATURE (CER -CLINICAL EVALUATION REPORT (B)(4)) THE RISK OF PAIN IS A KNOWN RISK THAT HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE (B)(4). EVENT OF PAIN ADDRESSED IN THE IFU WARNINGS AND PRECAUTIONS SECTION: "METALLIC IMPLANTS CAN LOOSEN, FRACTURE, CORRODE, MIGRATE, OR CAUSE PAIN".

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE PATIENT COMPLAINED ABOUT PAIN. THE SURGEON DECIDED TO REMOVE THE IMPLANT. REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545192 MID-C 105 POSTERIOR RATCHETING ROD SYSTEM,,, QGP APIFIX LTD MID-C 105 AF 11-04-17

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention