BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 105

    MDR report key: 12688577 · Received October 25, 2021

    Report

    Report Number
    3013461531-2021-00037
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    October 4, 2021
    Report Date
    October 23, 2021
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIRST INVESTIGATION: PRODUCTION PROCESS ANALYSIS: A REVIEW OF THE DHR DEMONSTRATED THAT THE MID-C SYSTEM WAS MANUFACTURED, TESTED, AND RELEASED ACCORDING TO SPECIFICATION. USER (SURGEON AND PATIENT) INFORMATION ANALYSIS: THE TISSUE WAS SENT FOR LABORATORY ANALYSIS, A FULL INVESTIGATION WILL BE DONE ONCE THE IMPLANT ARRIVES AT APIFIX.. DESIGN: THE MID-C IMPLANT IS COATED WITH ADLC COATING ON ALL MOVING PARTS WHICH REDUCES THE AMOUNT OF WEAR DEBRIS. THE COATING DESIGN WAS VALIDATED AND APPROVED FOR ITS USE. EVALUATION OF LOCAL AND SYSTEMATIC EFFECTS OF WEAR DEBRIS DMS- 2909. DMS-761 MID-C V&V REPORT . DMS 4449 IN SILICO ANALYSIS AND TOXICOLOGICAL RISK ASSESSMENT OF EXTRACTABLE COMPOUNDS. FROM THE APIFIX MID-C SYSTEM DEVICE USED FOR THE TREATMENT OF ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS). DMS 4243 - ISO 10993-18 - CHEMICAL CHARACTERIZATION. ALSO, THE COATING PROCESS WAS VALIDATED PER OQ DMS-5522 AND PQ DMS-5588. RISK ASSESSMENT: THE RISK OF "WEAR DEBRIS FROM MOVING PARTS, DEGRADATION, LEACHABLE ON THE IMPLANT AND THE BODY" HAS BEEN ASSES ACCORDING TO RISK FILE DMS-777 REV Q HAZARD ID 21.6 AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE SURGEON DECIDED TO PERFORM ELECTIVE SURGERY TO REPLACE THE EXISTING MID-C ROD IMPLANT WITH A LONGER SIZE IMPLANT SINCE THE PATIENT HAS GROWN AND THE IMPLANT REACHED ITS MAXIMAL ELONGATION. DURING THE REOPERATION, THE SURGEON DETECTED A BLACK DISCOLORATION OF THE TISSUE IN AREA OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591705 MID-C 105 POSTERIOR RATCHETING ROD SYSTEM,,, QGP APIFIX LTD MID-C 105 AF 11-01-17

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention