BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS INC.

    MDR report key: 20217939 · Received September 13, 2024

    Report

    Report Number
    3006742481-2024-00012
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 12, 2024
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    KWI
    UDI-DI
    00841506100043
    PMA / PMN Number
    K172688
    Product Problem
    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 INCLUDES THE FOLLOWING WARNINGS: "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 HEAD ALIGNMENT TOOL MUST BE USED DURING THE PROCEDURE TO CORRECTLY ALIGN THE PROSTHETIC HEAD AND TO PROVIDE THE NECESSARY COUNTER-TORQUE WHEN TIGHTENING THE LOCK SCREW." "THE LOCK SCREW PACKAGED WITH THE RADIAL HEAD MUST BE INSTALLED AND FULLY TIGHTENED TO FIX THE RADIAL HEAD TO THE RADIAL STEM. 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." THE ATTENDING SALES REP FOR THE INITIAL CASE CLAIMS THAT THE SURGEON HAD TROUBLE INSERTING THE SCREW, INDICATING THAT IT MAY NOT HAVE BEEN INSERTED CORRECTLY AND/OR SUFFICIENTLY TIGHTENED.

    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
    1208281 SKELETAL DYNAMICS INC. ALIGN RADIAL HEAD SYSTEM KWI SKELETAL DYNAMICS INC. AN2111046 00841506100043

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention