BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 24990542 · Received April 24, 2026

    Report

    Report Number
    3006742481-2026-00004
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 14, 2025
    Report Date
    April 24, 2026
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    KWI
    UDI-DI
    00841506100166
    PMA / PMN Number
    K172688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE ALIGN RADIAL HEAD SYSTEM STATES THE FOLLOWING: "THE ALIGN RADIAL HEAD SYSTEM SHOULD NOT BE USED IF ANY OF THE FOLLOWING ARE PRESENT: ACTIVE OR LATENT INFECTION, INSUFFICIENT QUANTITY OR QUALITY OF BONE AND/OR SOFT TISSUE, MATERIAL SENSITIVITY, OR PATIENTS WHO ARE UNWILLING OR INCAPABLE OF FOLLOWING POST-SURGICAL CARE INSTRUCTIONS." "RADIAL HEAD PROSTHESIS CANNOT BE EXPECTED TO WITHSTAND THE ACTIVITY LEVELS AND LOADS OF NORMAL HEALTHY BONE AND JOINT TISSUE. FAILURE OF THE COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE LOADS (ESTIMATED BODY WEIGHT EQUIVALENT OF 350 LBS OR GREATER)." "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT, OR FIXATION OF THE IMPLANTED COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS, WHICH MAY LEAD TO A SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." "MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE PROSTHESIS OR ANATOMICAL STRUCTURES." "THE PATIENT MUST BE CAUTIONED ABOUT THE USE, LIMITATIONS, AND POSSIBLE ADVERSE EFFECTS OF THIS DEVICE, INCLUDING THE POSSIBILITY OF DEVICE OR TREATMENT FAILURE AS A RESULT OF LOOSENING, STRESS, EXCESSIVE ACTIVITY, OR WEIGHT BEARING OR LOAD BEARING, AND THE POSSIBILITY OF NERVE OR SOFT TISSUE DAMAGE RELATED TO EITHER SURGICAL TRAUMA OR THE PRESENCE OF THE DEVICE." "POTENTIAL ALIGN RADIAL HEAD SYSTEM CONSTRUCT FAILURES, SUCH AS STRESS FRACTURES OF THE BONES, LOOSENING OF THE CONSTRUCT AND/OR FIXATION, DELAYED UNION, UNION, OR INCOMPLETE HEALING, MAY OCCUR AS A RESULT OF NON-COMPLIANCE WITH POST-SURGERY REHABILITATION, EXCESSIVE WRIST AND FOREARM ACTIVITIES, OR CONSTRUCT OVERLOADING." "PATIENT MUST AVOID PLACING EXCESSIVE LOADS ON THE IMPLANT." ENGAGING IN STRENUOUS ACTIVITY SUCH AS WEIGHTLIFTING CARRIES A KNOWN RISK OF TREATMENT FAILURE. THE PATIENT EXPERIENCING PAIN WHILE WEIGHTLIFTING 1 YEAR SUGGESTS THAT THE CONSTRUCT IS BEING STRESSED, WITH IMPROPER IMPLANTATION BEING A POTENTIAL CONTRIBUTING FACTOR.

    Description of Event or Problem · 0

    A PATIENT IS EXPERIENCING ELBOW PAIN WHILE LIFTING WEIGHTS ONE YEAR AFTER IMPLANTATION OF AN ALIGN RADIAL HEAD CONSTRUCT, REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568489 SKELETAL DYNAMICS INC. ALIGN RADIAL HEAD SYSTEM KWI SKELETAL DYNAMICS INC. AN2403045 00841506100166

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention