BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24410630 · Received February 22, 2026

    Report

    Report Number
    1220246-2026-00740
    Event Type
    Injury
    Date Received
    February 22, 2026
    Date of Event
    October 1, 2019
    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

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: ON 23 JAN 2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED ON NOVEMBER 2016 BY THE FOOT AND ANKLE INT. ¿EFFECTIVENESS OF HEADLESS BIOABSORBABLE SCREWS FOR FIXATION OF THE SCARF OSTEOTOMY.¿ THE STUDY REVIEWED 115 PATIENTS AND IDENTIFIED THAT EPIPHYSEAL DEFICIENCIES IN 1 PATIENT DURING THE YEAR FOLLOW-UP. IT WAS IDENTIFIED THAT 14 PATIENTS EXPERIENCE HALLUX VALGUS DEFORMITY A YEAR POST OP. 9 PATIENT WAS DETERMINED TO HAVE A REPORTED A REDUCED RANGE OF MOTION. REFERENCE: KIM JS, CHO HK, YOUNG KW, LEE SY, KIM JS, LEE K. EFFECTIVENESS OF HEADLESS BIOABSORBABLE SCREWS FOR FIXATION OF THE SCARF OSTEOTOMY. FOOT ANKLE INT. NOV 2016;37(11):1189-1196. DOI:10.1177/1071100716661826.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201576 UNK PIN, FIXATION, SMOOTH, METALLIC NDL ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1