BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL SUPERIOR AUGMENT GLENOID PLATE

    MDR report key: 19630182 · Received June 27, 2024

    Report

    Report Number
    1038671-2024-02200
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    June 17, 2024
    Report Date
    August 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862534873
    PMA / PMN Number
    K180632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 320-31-36 - GLENOSPHERE, 36MM: B033383. 320-35-02 - SMALL SUPERIOR AUGMENT GLENOID PLATE: B005369. 322-10-00 - HUMERAL ADAPTER TRAY, +0: A924190. 322-36-00 - 145-DEG PE 36MM HUM LINER +0: B057760. 320-15-05 - EQ REV LOCKING SCREW: A960713. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: B068998. 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: S314758. 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM: S525843. 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM: S499963. 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM: 6403736. 315-35-00 - GLND KWIRE: B053731. 315-35-00 - GLND KWIRE: B053732. 315-35-00 - GLND KWIRE: B054305. 531-20-00 - SHLDR GPS RVRS DRILL KIT: A180021. 531-78-20 - SHOULDR GPS HEX PINS KIT: A786943. A10012 - GPS IMPLANT KIT V2: 02000624060. 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM: A968242.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, D4, D6A, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, F, G. THE REASON FOR THE INTRAOPERATIVE BONE FRACTURE REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO A PATIENT CONDITION OR HIGH FORCES DURING REAMING. HOWEVER, THIS CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    INTRA-OPERATIVELY, THE INFERIOR GLENOID WAS FRACTURED DURING REAMING WITH THE K-WIRE IN PLACE. FIXATION WAS ACHIEVED WITH BASEPLATE SCREWS. THE SURGEON USED INTRA-OP STABILIZATION TO RESOLVE EVENT AND THE CASE REPORT INDICATED THAT IT IS DEFINITELY NOT RELATED TO THE DEVICE(S) BUT IS DEFINITELY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206552 SMALL SUPERIOR AUGMENT GLENOID PLATE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862534873

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female SEE H11.