BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RETRACTOR

    MDR report key: 16628316 · Received March 28, 2023

    Report

    Report Number
    1038671-2023-00521
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    February 17, 2023
    Report Date
    May 18, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) UPON REVIEW, THERE IS NO INDICATION THAT THERE IS A DEVICE RELATED PROBLEM, THERE IS NO ALLEGATION AGAINST THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS RELATED TO THE UNDERLYING PATIENT CONDITION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 78 YO MALE PATIENT HAS AVN (AVASCULAR NECROSIS) WITH SOFT BONE AND WHILE RETRACTING FOR GLENOID EXPOSURE THE GREATER TUBEROSITY FRACTURED. THE DATE OF ADVERSE EVENT ONSET IS 02-17-2023. THE ACTIONS TAKEN WAS THE USE OF STANDARD STEM AND FIBER WIRE THROUGH TUBEROSITY. THE PATIENT WAS REVISED BY REMOVAL OF COMPONENTS. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. (D1) BRAND NAME: SHOULDER COMPONENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 78 YO MALE PATIENT HAS AVN (AVASCULAR NECROSIS) WITH SOFT BONE AND WHILE RETRACTING FOR GLENOID EXPOSURE THE GREATER TUBEROSITY FRACTURED. THE DATE OF ADVERSE EVENT ONSET IS 02-17-2023. THE ACTIONS TAKEN WAS THE USE OF STANDARD STEM AND FIBER WIRE THROUGH TUBEROSITY. THE PATIENT WAS REVISED BY REMOVAL OF COMPONENTS. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 78 YO MALE PATIENT HAS AVN (AVASCULAR NECROSIS) WITH SOFT BONE AND WHILE RETRACTING FOR GLENOID EXPOSURE THE GREATER TUBEROSITY FRACTURED. THE DATE OF ADVERSE EVENT ONSET IS (B)(6) 2023. THE ACTIONS TAKEN WAS THE USE OF STANDARD STEM AND FIBER WIRE THROUGH TUBEROSITY. THE PATIENT WAS REVISED BY REMOVAL OF COMPONENTS. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610679 UNKNOWN RETRACTOR PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1