BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 23500980 · Received November 7, 2025

    Report

    Report Number
    3006742481-2025-00009
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    June 16, 2025
    Report Date
    November 6, 2025
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    KWI
    PMA / PMN Number
    K172688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE FOR THE ALIGN RADIAL HEAD SYSTEM STATES THE FOLLOWING: "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). " "THE LOCK SCREW PACKAGED WITH THE RADIAL HEAD MUST BE INSTALLED AND FULLY TIGHTENED TO FIX THE RADIAL HEAD TO THE RADIAL STEM. THE RADIAL HEAD PROSTHESIS IS DESIGNED TO BECOME A MONOBLOCK FOLLOWING FIXATION OF THE LOCK SCREW. IF THE LOCK SCREW IS NOT ATTACHED AND/OR FULLY SECURED, THE RADIAL HEAD MAY LOOSEN AND/OR DISCONNECT FROM THE RADIAL STEM, CAUSING SOFT TISSUE IRRITATION AND/OR DEVICE FAILURE." "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT OR FIXATION OF THE IMPLANTED COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO 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 ALIGN RADIAL HEAD ARTHROPLASTY SURGICAL TECHNIQUE GUIDE ADDITIONALLY WARNS NOT TO OVER-STUFF THE JOINT AND TO ENSURE THAT THE RADIAL STEM IS INSERTED TO A DEPTH COVERING AT LEAST HALF OF THE TPS-COATED AREA. THE FLUOROSCOPIC IMAGES FROM THE CASE INDICATE THAT THE RADIAL HEAD CONSTRUCT WAS LIKELY SIGNIFICANTLY OVER-STUFFED, WITH A LARGE PORTION OF THE TPS-COATED AREA ON THE RADIAL STEM LEFT EXPOSED. ALTHOUGH THE CONSTRUCT MAY NOT HAVE MALFUNCTIONED UNTIL AFTER A YEAR OF USE (WHICH EVIDENTLY INCLUDED FREQUENT STRENUOUS ACTIVITY), POOR INITIAL FIXATION OF THE RADIAL STEM WAS LIKELY PRIMARILY RESPONSIBLE FOR ITS EVENTUAL FAILURE.

    Description of Event or Problem · 0

    THE SET SCREW BACKED OUT OF AN IMPLANTED ALIGN RADIAL HEAD, REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925003 SKELETAL DYNAMICS INC. ALIGN RADIAL HEAD SYSTEM KWI SKELETAL DYNAMICS INC. AN2111037

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention