BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 23589355 · Received November 18, 2025

    Report

    Report Number
    2027754-2025-00061
    Event Type
    Injury
    Date Received
    November 18, 2025
    Report Date
    November 19, 2025
    Manufacturer
    OSTEOMED, LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE INFORMATION IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. BELOW ARE ALL RELATED REPORT NUMBERS REGARDING THIS LITERATURE REVIEW (6 TOTAL FOR THIS ARTICLE): NOTE, THIS MDR IS INCLUDED IN THE LIST BELOW. 2027754-2025-00057, 2027754-2025-00058, 2027754-2025-00059, 2027754-2025-00060, 2027754-2025-00062.

    Description of Event or Problem · 0

    A LITERATURE REVIEW IDENTIFIED THE ARTICLE, GAZIT T, ROBINSON D, KHAWALDE K, ET AL. FOOT SURGERY USING RESORBABLE MAGNESIUM SCREWS. THE JOURNAL OF FOOT AND ANKLE SURGERY: OFFICIAL PUBLICATION OF THE AMERICAN COLLEGE OF FOOT AND ANKLE SURGEONS. 2024 JAN-FEB;63(1):79-84. DOI: 10.1053/J.JFAS.2023.09.002. PMID: 37699499. IN THIS PROSPECTIVE CASE SERIES, 60 PATIENTS UNDERWENT CORRECTIVE HALLUX VALGUS SURGERY. THE STUDY COMPARED THE EFFECTS OF USING EITHER CANNULATED MAGNEZIX CS 3.2MM BIOABSORBABLE MAGNESIUM SCREWS (SYNTELLIX AG) OR 4.0MM EXTREMIFIX TITANIUM CANNULATED SCREWS (OSTEOMED). CONSECUTIVE PATIENTS WERE TREATED BETWEEN 2018 AND 2020. TWENTY-SIX (26) PATIENTS OPTED TO USE THE MAGNEZIX IMPLANTS VERSUS 34 PATIENTS THAT USED THE TITANIUM SCREWS. PATIENTS WERE FOLLOWED FOR AT LEAST 1 YEAR AND ASSESSED FOR THE AMERICAN ORTHOPEDIC FOOT AND ANKLE SOCIETY (AOFAS) HALLUX VALGUS SCORE, THE VISUAL ANALOG SCALE (VAS) SCORE, THE PATIENT'S GLOBAL IMPRESSION OF CHANGE (PGIC) SCORE, AND THE FIFTH METATARSUS CIRCUMFERENCE (IF5C) SCORE. IN ADDITION, RADIOGRAPHIC IMAGING OF THE INTERMETATARSAL AND HALLUX VALGUS ANGLES, OSTEOTOMY UNION, AND HARDWARE FAILURE WERE ALSO REVIEWED. IN THE MAGNESIUM SCREW GROUP, HARDWARE FAILURE OCCURRED IN 5 PATIENTS. SIX (6) PATIENTS WITH THE TITANIUM SCREW HAD THEIR HARDWARE REMOVED, WHILE NONE OF THE MAGNESIUM SCREWS WERE REMOVED. ALL PATIENTS ACHIEVED UNION BETWEEN 3 TO 4 MONTHS. NO OTHER COMPLICATIONS WERE REPORTED. THE AOFAS AND PGIC SCORES BETWEEN BOTH GROUPS WERE SIMILAR AT 12 MONTHS. OTHER FOOT SCORES AND RADIOGRAPHIC IMAGING ALSO SHOWED NO DIFFERENCES BETWEEN THE TWO TREATMENT METHODS. THE AUTHORS OF THE STUDY CONCLUDED THAT MAGNESIUM SCREWS ARE SAFE FOR HALLUX VALGUS SURGERY. WHILE THERE WAS AN INCREASED RISK OF HARDWARE FAILURE IN THE MAGNESIUM SCREW GROUP, THE PATIENTS ALSO HAD SLIGHTLY FASTER HEALING TIMES OF THEIR OSTEOTOMIES. THEY CONCLUDED THAT MAGNESIUM SCREW FIXATION IS NOT INFERIOR TO USING TRADITIONAL TITANIUM SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643727 SCREW, FIXATION, BONE HWC OSTEOMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O