BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24410600 · Received February 22, 2026

    Report

    Report Number
    1220246-2026-00730
    Event Type
    Injury
    Date Received
    February 22, 2026
    Date of Event
    October 1, 2024
    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 2024 BY THE HAND SURGICAL JOURNAL ¿CLINICAL, RADIOLOGICAL AND DYNAMIC CT RESULTS OF SCAPHOLUNATE INTERCARPAL LIGAMENTOPLASTY FOR SCAPHOLUNATE DISSOCIATION.¿ THE STUDY REVIEWED 29 PATIENTS AND IDENTIFIED SCAPHOLUNATE INSTABILITY WITH INTERFERENCE AND TENODESIS SCREWS IN 3 PATIENTS DURING THE 2-5 YEAR FOLLOW-UP PERIOD. IT WAS IDENTIFIED THAT 1 PATIENT EXPERIENCED COMPLEX REGIONAL PAIN SYNDROME. REF: ATHLANI L, LUC E, PAUCHARD N, BLUM A, DAUTEL G, GONDIM TEIXEIRA PA. CLINICAL, RADIOLOGICAL AND DYNAMIC CT RESULTS OF SCAPHOLUNATE INTERCARPAL LIGAMENTOPLASTY FOR SCAPHOLUNATE DISSOCIATION. HAND SURG REHABIL. OCT 2024;43(5):101762. DOI:10.1016/J.HANSUR.2024.101762.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250971 UNK PIN, FIXATION, SMOOTH, METALLIC NDL ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other