BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 23631054 · Received November 24, 2025

    Report

    Report Number
    3006742481-2025-00011
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    February 10, 2025
    Report Date
    November 21, 2025
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    KWI
    UDI-DI
    00841506100043
    PMA / PMN Number
    K172688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SKELETAL DYNAMICS WAS MADE AWARE OF THIS EVENT DURING A REVIEW OF THE MAUDE REPORT DATABASE CONDUCTED ON 10/30/2025. DUE TO THE LIMITED INFORMATION PROVIDED, A FULL INVESTIGATION COULD NOT BE CONDUCTED; HOWEVER, PREVIOUS INVESTIGATIONS INVOLVING FAILURES SIMILAR TO OR MATCHING THE EVENT DESCRIPTION HAVE CONSISTENTLY BEEN LINKED TO THE OCCURRENCE OF A TRAUMATIC EVENT.

    Description of Event or Problem · 0

    PER PREVIOUS MAUDE ADVERSE EVENT REPORT (REPORT NUMBER (B)(4)), AN ALIGN RADIAL HEAD WHICH HAD BEEN IMPLANTED FOR FOUR YEARS WAS REMOVED DUE TO BEING LOOSE WITH A PARTIALLY BACKED OUT SET SCREW, REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341616 SKELETAL DYNAMICS INC. ALIGN RADIAL HEAD SYSTEM KWI SKELETAL DYNAMICS INC. AN1907030 00841506100043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention