BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 17451888 · Received August 3, 2023

    Report

    Report Number
    1038671-2023-01685
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    March 17, 2023
    Report Date
    June 1, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: HUMERAL STEM OR STEMLESS 3006001, HUMERAL HEAD 3106241, GLENOID 3142422.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE 66 YO FEMALE PATIENT EXPERIENCED A SCAPULAR FRACTURE. THE CORACOID FRACTURE OCCURRED INTRA-OP, DURING THE CASE AT THE SITE OF THE TRACKER FIXATION. THE PATIENT WAS TREATED WITH SUTURING IN PLACE. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284645 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other| R SEE H10.