BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 10299776 · Received July 20, 2020

    Report

    Report Number
    3006742481-2020-00003
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    January 16, 2020
    Report Date
    February 3, 2020
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HSB
    PMA / PMN Number
    K092720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED UNIT SHOWED NO MARKS FROM AN INSERTED SCREW IN THE PROXIMAL AND DISTAL DEVICE SCREW HOLES. THE REPORTED COMPLAINT IS DUE TO PROCEDURE ERROR AS THERE WAS EVIDENCE OF MISSING SCREW PLACEMENTS VIA FLUOROSCOPY.

    Description of Event or Problem · 1

    SURGEON PERFORMED A PLATE REMOVAL FOR FRACTURED NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763772 SKELETAL DYNAMICS WRIST ARTHRODESIS NAIL SYSTEM HSB SKELETAL DYNAMICS AZ0710004

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other