BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS ASCEND FLEX SHOULDER PROSTHESIS

    MDR report key: 7937917 · Received October 5, 2018

    Report

    Report Number
    3000931034-2018-00148
    Event Type
    Injury
    Date Received
    October 5, 2018
    Report Date
    September 13, 2018
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    PMA / PMN Number
    K122698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE SOURCE OF THIS REPORT LITERATURE : "INCREASED SCAPULAR SPINE FRACTURES AFTER REVERSE SHOULDER ARTHROPLASTY WITH A HUMERAL ONLAY SHORT STEM: AN ANALYSIS OF 485 CONSECUTIVE CASES" FRANCESCO ASCIONE FET AL., J SHOULDER ELBOW SURG, 2018 (JSE.2018.06.007).

    Description of Event or Problem · 1

    "FROM LITERATURE : ""INCREASED SCAPULAR SPINE FRACTURES AFTER REVERSE SHOULDER ARTHROPLASTY WITH A HUMERAL ONLAY SHORT STEM: AN ANALYSIS OF 485 CONSECUTIVE CASES"" FRANCESCO ASCIONE FET AL., J SHOULDER ELBOW SURG, 2018 (JSE.2018.06.007). 21 PATIENTS HAD SCAPULAR SPINE FRACTURE: NONOPERATIVE TREATMENT WAS USED IN 19 PATIENTS; 2 PATIENTS UNDERWENT ORIF (1 FOLLOWING SPINE NONUNION AND PERSISTENT PAIN; 1 AFTER A FALL AND CONSEQUENT FAILURE OF THE PREVIOUS PLATE FIXATION)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780391 AEQUALIS ASCEND FLEX SHOULDER PROSTHESIS SHOULDER JOINT METAL PROSTHESIS KWS TORNIER S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other