BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0 FASTENER

    MDR report key: 18288425 · Received December 7, 2023

    Report

    Report Number
    3011656326-2023-00005
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    June 14, 2021
    Report Date
    December 7, 2023
    Manufacturer
    OSTEOCENTRIC TECHNOLOGIES, INC.
    Product Code
    HWC
    PMA / PMN Number
    K150981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER UPDATES, & REPORT SOURCE UPDATE: THIS REPORT UPDATES THE INITIAL REPORTER INFORMATION TO THE PHYSICIAN WHO INITIALLY REPORTED THE ISSUE AND INCLUDES THE REPORT SOURCE OF HOW THE ISSUE BECAME KNOWN BY OSTEOCENTRIC TECHNOLOGIES, INC.

    Description of Event or Problem · 0

    A 3 HOLE PLATE WAS USED WITH A 4.0 FASTENER (LENGTH UNKNOWN) BACKED OUT A VERY SMALL AMOUNT AND HAS NOT BEEN REMOVED FROM THE PATIENT DUE TO NOT CAUSING ANY FURTHER RISK OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198034 4.0 FASTENER HWC OSTEOCENTRIC TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other