BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MID-C 125

    MDR report key: 12688640 · Received October 25, 2021

    Report

    Report Number
    3013461531-2021-00036
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    September 24, 2021
    Report Date
    October 22, 2021
    Manufacturer
    APIFIX LTD
    Product Code
    QGP
    PMA / PMN Number
    H170001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 PATIENT WAS IMPLANTED WITH A STANDARD PEDICLE SCREW. THE SCREW HAS A COUNTER TORQUE FEATURE (SCREW POST), WHICH PROTRUDES OVER THE M6 THREAD WHICH MAY BE THE SOURCE OF PAIN HAS BEEN REPORTED IN SOME PATIENTS. REGARDING THE LOSS OF LORDOSIS OF THIS PATIENT, APIFIX CTO EVALUATED AND DETERMINE THAT THE LOSS OF LORDOSIS IS VERY MINIMAL AND THE SVA IMPROVED. IMPLANTATION OF THE SYSTEM IN L4 IS ASSOCIATED WITH SOME LOSS OF LORDOSIS BUT NOT IN THE RANGE REACHING CLINICAL SIGNIFICANCE. CORRECTIVE ACTION: THE DESIGN OF THE PEDICEL SCREW WAS IMPROVED TO HAVE LOW PROFILE (LP) PEDICLE SCREWS TO BETTER FIT SMALL/THIN PATIENTS AT RISK FOR POTENTIAL SKIN IRRITATION DUE TO THE COUNTER TORQUE FEATURE (SCREW POST), WHICH PROTRUDES OVER THE M6 THREAD IN THE STANDARD SCREWS. THE LP PEDICLE SCREW COUNTER-TORQUE FEATURE IS NOW CONTAINED INTERNALLY IN THE PEDICLE SCREW INSTEAD OF PROTRUDING ABOVE THE NUT, AN INTERNAL FEMALE TORX CONNECTION IS BEING USED INSIDE THE THREADED PORTION OF THE SCREW, ALLOWING THE HEIGHT OF THE SCREW TO BE REDUCED, RESULTING IN A LOWER PROFILE. THE LP SCREWS ARE MORE COMPATIBLE WITH THIN PATIENTS. RISK ASSESSMENT: PAIN ASSOCIATED WITH SCOLIOSIS IS WELL DESCRIBED IN THE LITERATURE REGARDLESS OF HAVING CORRECTIVE SURGERY. PAIN CAN ALSO BE A TRANSIENT COMPLAINT ASSOCIATED WITH THE SURGICAL PROCEDURE OR BE SECONDARY TO DEVICE FAILURE, INFECTION/INFLAMMATION, CURVE PROGRESSION, SCREW PULL-OUT, LOOSENING, MIGRATION, PROTRUSION AND PROMINENCE. AT THE TIME OF THIS REPORT, WE DON'T HAVE A DEFINITE CAUSE FOR THE PATIENT COMPLAINT OF PAIN. AT THE TIME OF THIS REPORT (OCT 04, 2021), THE COMPANY'S INCIDENT RATE OF PAIN IS (B)(4) WHICH IS WELL WITHIN THE RATE REPORTED IN THE LITERATURE ( CER -CLINICAL EVALUATION REPORT DMS-727 REV T. (B)(4) ) THE RISK OF PAIN IS A KNOWN RISK THAT HAS BEEN ASSESSED AND FOUND TO BE ACCEPTABLE (DMS#777 REV Q1). 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 PATIENT SUFFERED FROM PAIN IN THE REGION OF THE LOWER APIFIX SCREW. IN ADDITION TO THE LOSS OF LORDOSIS FOR HIS LENKE 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591206 MID-C 125 POSTERIOR RATCHETING ROD SYSTEM,, QGP APIFIX LTD MID-C 125 AF 10-01-19

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention