BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24410590 · Received February 22, 2026

    Report

    Report Number
    1220246-2026-00725
    Event Type
    Injury
    Date Received
    February 22, 2026
    Date of Event
    November 1, 2021
    Report Date
    February 22, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    NDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    EVENT DESCRIPTION: ON 23 JAN 2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED ON NOV 2021 BY THE JOURNAL OF FOOD AND ANKLE SURGERIES ¿EXTENDED DISTAL CHEVRON OSTEOTOMY AND AKIN OSTEOTOMY USING BIOABSORBABLE MATERIALS FOR TREATMENT OF MODERATE TO SEVERE HALLUX VALGUS.¿ THE STUDY REVIEWED 42 PATIENTS IDENTIFIED THAT EPIPHYSEAL DEFICIENCIES IN 1 PATIENT DURING THE 3-YEAR FOLLOW-UP FOR THE TRIM-IT PINS. IT WAS IDENTIFIED THAT 1 PATIENT EXPERIENCED HALLUX VARUS. REF: SONG JH, KANG C, PARK WH, ET AL. EXTENDED DISTAL CHEVRON OSTEOTOMY AND AKIN OSTEOTOMY USING BIOABSORBABLE MATERIALS FOR TREATMENT OF MODERATE TO SEVERE HALLUX VALGUS. J FOOT ANKLE SURG. NOV-DEC 2021;60(6):1110-1116. DOI:10.1053/J.JFAS.2021.01.010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471878 UNK PIN, FIXATION, SMOOTH, METALLIC NDL ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown