BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T2 ALPHA - DISTAL TARGETING DEVICE HUMERUS

    MDR report key: 25298756 · Received May 27, 2026

    Report

    Report Number
    0008031020-2026-00699
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    April 25, 2026
    Report Date
    May 27, 2026
    Manufacturer
    STRYKER GMBH
    Product Code
    HSB
    UDI-DI
    07613327646177
    PMA / PMN Number
    K251400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    DR. (B)(6) IMPLANTED AN 8X240MM T2 ALPHA HUMERUS NAIL, LONG, WITH USE OF THE DTD FOR TREATMENT OF A NON-UNION IN THE HUMERAL SHAFT. ¿ "MISSED THE AP SCREW." [REPORTED AS AN OBSERVED DEFICIENCY / COMPLICATION].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480829 T2 ALPHA - DISTAL TARGETING DEVICE HUMERUS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH UNKNOWN 07613327646177

    Patients

    Seq Age Sex Outcome Treatment
    1