BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0 X 38MM SCREW SUPER FASTENER, ST

    MDR report key: 18296872 · Received December 8, 2023

    Report

    Report Number
    3011656326-2023-00014
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    July 19, 2022
    Report Date
    December 8, 2023
    Manufacturer
    OSTEOCENTRIC TECHNOLOGIES, INC.
    Product Code
    HWC
    UDI-DI
    00810074300131
    PMA / PMN Number
    K150981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SPECIFIC ROOT CAUSE COULD BE DETERMINED, ALL FASTENERS RETURNED WERE BUILT TO SPECIFICATION, NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    UDI RELEATED DATA QUALITY UPDATES, PRODUCT INFORMATION UPDATE, INITIAL REPORTER UPDATES, & REPORT SOURCE UPDATE: THIS FOLLOW-UP REPORT INCLUDES THE ADDITION OF THE BRAND NAME, MODEL NUMBER, AND FULL UDI, WHICH WERE MISSING FROM THE INITIAL REPORT. THE 510(K) WAS UPDATED. THE LOT # AND MANUFACTURING DATE ARE ON THE DEVICE LABEL, BUT ARE NOT ON THE LABEL AS A PI. THIS REPORT SPECIFIES THAT THIS IS NOT A COMBINATION PRODUCT AND THAT THE PRODUCT IS FOR SINGLE USE. ADDITIONALLY, 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

    FOR A ORIF PROXIMAL HUMERUS SURGERY, A COMBINATION OF 4.0MM LOCKING FASTENERS & 4.0MM FASTENERS WERE USED IN THE HEAD OF THE PLATE, WHILE 3.5MM FASTENERS WERE IMPLANTED IN THE DISTAL OR SHAFT SEGMENT. TWO LOCKING PROX HUM FASTENERS BACKED OUT AND ONE NON LOCKING FASTENER BACKED OUT. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272966 4.0 X 38MM SCREW SUPER FASTENER, ST 4.0 X 38MM SCREW SUPER FASTENER, ST HWC OSTEOCENTRIC TECHNOLOGIES, INC. 340-2038 DCW155 00810074300131

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other