BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24410732 · Received February 22, 2026

    Report

    Report Number
    1220246-2026-00772
    Event Type
    Injury
    Date Received
    February 22, 2026
    Date of Event
    October 1, 2016
    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

    ON 23 JAN 2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED ON OCTOBER 2016 BY THE ARCH ORTHOPEDIC TRAUMA SURGERY JOURNAL ¿INTERFERENCE SCREW FOR FIXATION OF FDL TRANSFER IN THE TREATMENT OF ADULT ACQUIRED FLAT FOOT DEFORMITY STAGE II.¿ THE STUDY REVIEWED 21 PATIENTS AND IDENTIFIED ANKLE INSTABILITY REQUIRING REVISION WITH BIOABSORBABLE INTERFERENCE SCREWS IN 1 PATIENT DURING THE 2-YEAR FOLLOW-UP PERIOD. REF: CHARWAT-PESSLER CG, HOFSTAETTER SG, JAKUBEK DE, TRIEB K. INTERFERENCE SCREW FOR FIXATION OF FDL TRANSFER IN THE TREATMENT OF ADULT ACQUIRED FLAT FOOT DEFORMITY STAGE II. ARCH ORTHOP TRAUMA SURG. OCT 2015;135(10):1369-78. DOI:10.1007/S00402-015-2295-6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471807 UNK PIN, FIXATION, SMOOTH, METALLIC NDL ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown