BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFIX ILIAC SCREW SYSTEM

    MDR report key: 24516065 · Received March 5, 2026

    Report

    Report Number
    3003200961-2026-00002
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    September 24, 2024
    Report Date
    March 5, 2026
    Manufacturer
    CG MEDTECH CO., LTD.
    Product Code
    MNH
    UDI-DI
    08800015931816
    PMA / PMN Number
    K132218
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FRACTURE LOCATION IS CONSIDERED TO BE AT THE START OF THE SCREW'S THREAD TRANSITION REGION. BASED ON OUR REVIEW, THE FRACTURE LOCATION IS ASSESSED TO BE AT THE TRANSITION AREA WHERE THE INCOMPLETE THREAD BEGINS. THIS TRANSITION AREA CAN BE MORE SUSCEPTIBLE TO LOCALIZED STRESS CONCENTRATION DUE TO THE CHANGE IN THE CORE DIAMETER GEOMETRY. FROM THE X-RAY IMAGES, THE SACROPELVIC FIXATION IS PRESUMED TO HAVE BEEN PERFORMED USING THE S2-ALAR-ILIAC (S2AI) TECHNIQUE. WITH THE S2AI CONFIGURATION, THE TRANSITION AREA MAY OVERLAP WITH THE SI JOINT BOUNDARY REGION, WHICH COULD INCREASE THE INFLUENCE OF LOAD TRANSFER AND POTENTIAL MICRO-MOTION. IN ADDITION, CONSIDERING THAT THE FRACTURE WAS IDENTIFIED APPROXIMATELY 10 MONTHS POST-OPERATIVELY, THERE IS A HIGHER POSSIBILITY OF A DELAYED UNION ASSOCIATED WITH OSTEOPOROSIS. IN SUCH CIRCUMSTANCES, PHYSIOLOGICAL LOAD SHARING MAY NOT BE ADEQUATELY TRANSFERRED THROUGH THE SURROUNDING BONE TISSUE. CONSISTENT WITH THIS, THE LITERATURE REPORTS THAT OSTEOPOROSIS IS ASSOCIATED WITH AN APPROXIMATELY 3.7-FOLD INCREASED RISK OF IMPLANT FAILURE (CHOI ET AL., 2020). THE COMBINED EFFECT OF THESE FACTORS MAY HAVE CONTRIBUTED TO SUSTAINED FATIGUE LOADING CONCENTRATION AT THE TRANSITION AREA OVER TIME, ULTIMATELY PROGRESSING TO FRACTURE.

    Description of Event or Problem · 0

    IN (B)(6) 2024, APPROXIMATELY 10 MONTHS AFTER THE INITIAL SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT PRESENTED WITH PAIN AND DISCOMFORT. X-RAY IMAGING CONFIRMED A FRACTURE OF THE ILIAC SCREW BODY, AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE FRACTURED SCREW. THE PATIENT'S SYMPTOMS HAVE IMPROVED FOLLOWING THE REVISION PROCEDURE. ACCORDING TO THE PATIENT'S STATEMENT, PERSISTENT PAIN HAD BEEN PRESENT SINCE SCREW IMPLANTATION, AND THERE WAS PROLONGED HOSPITALIZATION DUE TO A FISTULA AND INFECTION. THE INVOLVED DEVICE WAS ILIAC SCREW - 9.5X100 MM (LOT NO. 14K294). REVIEW OF MANUFACTURING AND INSPECTION RECORDS CONFIRMED THAT COMPLIANT RAW MATERIAL WITHIN THE REQUIRED CHEMICAL COMPOSITION AND MECHANICAL PROPERTY SPECIFICATIONS WAS USED, AND THAT THE DEVICE GEOMETRY, DIMENSIONS, AND VISUAL APPEARANCE MET APPLICABLE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579377 PERFIX ILIAC SCREW SYSTEM ORTHOSIS, SPONDYLOLISTHESIS SPIN MNH CG MEDTECH CO., LTD. SL9510 14K294 08800015931816

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Hospitalization| R