BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8304751 · Received February 5, 2019

    Report

    Report Number
    1038671-2019-00046
    Event Type
    Injury
    Date Received
    February 5, 2019
    Report Date
    February 27, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K131575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (A1) PATIENT IDENTIFIER (IN CONFIDENCE): (B)(6). (B2) OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED. (D4) CATALOG NUMBER: 320-15-08, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 20-SEP-2026, UNIQUE IDENTIFIER (UDI) #: (B)(4). (E3) OCCUPATION: PHYSICIAN. (G5) PMA/510(K)NUMBER: K131575. (H4) DEVICE MANUFACTURE DATE: 20-SEP-2016. (H7) EVALUATION CODES: 1924, 4002. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D1) BRAND NAME: EQUINOXE. (D2) COMMON DEVICE NAME: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE. (E1) INITIAL REPORTER NAME: DR. (B)(6). (E2) HEALTH PROFESSIONAL?: YES. (G1) MDR REPORTING CONTACT NAME: (B)(4). (G3) REPORT SOURCE: HEALTH PROFESSIONAL. (H3) THE GLENOID BASEPLATE LOOSENING REPORTED WAS LIKELY THE RESULT OF THE SCREW(S) FRACTURING. THE UNDERLYING CAUSE OF THE SCREW FRACTURE IS UNKNOWN BUT MAY HAVE BEEN THE RESULT OF THE REPORTED PATIENT FALL. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES HAVE NOT BEEN REVISED AND, THEREFORE, ARE NOT AVAILABLE FOR EVALUATION, AND NO FURTHER INFORMATION WAS PROVIDED. *NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): B6, B7, D7, G8, H7, H9.

    Additional Manufacturer Narrative · 1

    THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. PENDING EVALUATION.

    Description of Event or Problem · 1

    INDEX SURGERY: (B)(6) 2016. ASEPTIC GLENOID LOOSENING. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98597 EQUINOXE SUP/POST AUG PLATE, R RS GLENOID BASEPLATE KWT EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R