BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 15372852 · Received September 7, 2022

    Report

    Report Number
    3006742481-2022-00008
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    August 8, 2022
    Report Date
    September 7, 2022
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    KWI
    UDI-DI
    00841506100067
    PMA / PMN Number
    K172688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RADIAL HEAD WAS ORIGINALLY IMPLANTED BY A DIFFERENT SURGEON 7 YEARS PRIOR TO REMOVAL. THERE WERE NO REPORTS OF PATIENT INJURY. THE REMOVAL AND REPLACEMENT PROCEDURE WAS SUCCESSFUL. THE INITIAL REPORTER DID NOT REPORT ANY ISSUES REGARDING THE PATIENT OR THE REVISION. NO OTHER INFORMATION WAS PROVIDED REGARDING THIS FAILURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    A SCREW DISENGAGED FROM A RADIAL HEAD IMPLANT. THE IMPLANT WAS REMOVED. NO PATIENT INJURY OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232462 SKELETAL DYNAMICS ALIGN RADIAL HEAD SYSTEM KWI SKELETAL DYNAMICS ALIGN Radial Stem, 7mm x 0mm 00841506100067

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention