BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOCENTRIC 4.0 X 48MM LOCKING BONE SCREW FASTENER ST

    MDR report key: 18296840 · Received December 8, 2023

    Report

    Report Number
    3011656326-2023-00013
    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
    00816950027529
    PMA / PMN Number
    K190430
    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 RELATED DATA QUALITY UPDATES, PRODUCT INFORMATION UPDATE, INITIAL REPORTER UPDATES, REPORT SOURCE, & OPERATOR 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 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. THIS REPORT ADDS THE OPERATOR OF THE DEVICE. 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 2 OF 3 FOR OT-22-012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264020 OSTEOCENTRIC 4.0 X 48MM LOCKING BONE SCREW FASTENER ST 4.0 X 48MM LOCKING BONE SCREW FASTENER, ST HWC OSTEOCENTRIC TECHNOLOGIES, INC. 340-6048 CCW017 00816950027529

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other