BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTUS TEMPORARY TENSION BOLT

    MDR report key: 4360437 · Received November 6, 2014

    Report

    Report Number
    3005215824-2014-00001
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 11, 2014
    Report Date
    November 6, 2014
    Manufacturer
    MEDARTIS, INC.
    Product Code
    LXH
    Removal / Correction Number
    3005215824-100214-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, DR (B)(6) AT THE HOSPITAL FOR SPECIAL SURGERY IN (B)(6) CARRIED OUT AN ULNA SHORTENING WHERE THE TENSION BOLT BROKE DURING COMPRESSION. THE SURGEON COMPLETED THE CASE SUCCESSFULLY BY MANUAL COMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716253 APTUS TEMPORARY TENSION BOLT TEMPORARY TENSION BOLT LXH MEDARTIS, INC. A-2791.05 14125026

    Patients

    Seq Age Sex Outcome Treatment
    1 Other