BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 11456582 · Received March 10, 2021

    Report

    Report Number
    3006742481-2021-00002
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 10, 2021
    Report Date
    March 8, 2021
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HWC
    UDI-DI
    00841506101835
    PMA / PMN Number
    K201662
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE PROVIDE THAT THE USER SELECTS THE TYPE AND SIZE OF IMPLANT TO BEST MEET THE PATIENT'S NEEDS. IT ALSO STATE THAT THE DEVICE IS NOT DESIGNED TO WITHSTAND THE STRESS OF WEIGHT BEARING, LOAD BEARING, OR EXCESSIVE PHYSICAL ACTIVITY, AND THAT DEVICE BREAKAGE MAY OCCUR WHEN THE DEVICE IS SUBJECTED TO EXCESSIVE LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION.

    Description of Event or Problem · 1

    BROKEN SCREW POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349394 SKELETAL DYNAMICS HEADLESS COMPRESSION SCREW HWC SKELETAL DYNAMICS Screw, Headless Compression, 2.5mm x 10mm, Ti 00841506101835

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention