BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PRIMARY TARGETING DEVICE

    MDR report key: 25298757 · Received May 27, 2026

    Report

    Report Number
    0008031020-2026-00700
    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
    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
    563543 UNKNOWN PRIMARY TARGETING DEVICE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1