BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIGN

    MDR report key: 12522609 · Received September 23, 2021

    Report

    Report Number
    3006742481-2019-00005
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    December 4, 2019
    Report Date
    September 22, 2021
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    KWI
    UDI-DI
    00841506100210
    PMA / PMN Number
    K172688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED AND THEREFORE NO PHYSICAL INVESTIGATION COULD BE PERFORMED. BASED ON THE LIMITED INFORMATION AVAILABLE, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT.

    Description of Event or Problem · 1

    BROKEN STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420391 ALIGN RADIAL HEAD SYSTEM KWI SKELETAL DYNAMICS ALIGN Radial Stem, 10mm x 0mm AN0913063 00841506100210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention