BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 16892650 · Received May 8, 2023

    Report

    Report Number
    3006742481-2023-00009
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    April 11, 2023
    Report Date
    May 8, 2023
    Manufacturer
    SKELETAL DYNAMICS INC.
    Product Code
    KWI
    UDI-DI
    00841506100043
    PMA / PMN Number
    K172688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE OF THIS DEVICE STATES: THE LOCKING SCREW PACKAGED WITH THE RADIAL HEAD MUST BE INSTALLED AND FULLY TIGHTENED TO FIX THE RADIAL HEAD TO THE RADIAL STEM. IF THE LOCKING 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. THIS IS A COMMON CAUSE OF FAILURE IN RADIAL HEAD CASES. THE LOCKING SCREW AND RADIAL HEAD WERE BOTH INSPECTED AND FOUND TO BE WITHIN SPECIFICATION. HOWEVER, THE RETURNED DEVICE IS CURRENTLY UNDERGOING FURTHER TESTING, AND A CONCLUSION HAS YET TO BE DETERMINED.

    Description of Event or Problem · 0

    RADIAL HEAD LOCKING SCREW LOOSENED. THE LOCKING SCREW WAS REPLACED SUCCESSFULLY, AND THERE ARE NO REPORTS OF FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726360 SKELETAL DYNAMICS ALIGN RADIAL HEAD SYSTEM KWI SKELETAL DYNAMICS INC. ALIGN Radial Head & Lock Screw, 24mm AN1907034 00841506100043

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention