BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMIS 01.15.10.0190 AMIS LEG POSITIONER 2.0 FRAME

    MDR report key: 14426901 · Received May 17, 2022

    Report

    Report Number
    3005180920-2022-00376
    Event Type
    Injury
    Date Received
    May 17, 2022
    Date of Event
    April 20, 2022
    Report Date
    May 17, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040735773
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 MAY 2022. LOT 1213121A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (NO CASES WERE REPORTED ON THE ORIGINAL LOT 1213121).

    Description of Event or Problem · 0

    SPIRAL FRACTURE FROM THE CENTER TO THE DISTAL PART OF THE TIBIAL DIAPHYSIS DURING EXTERNAL ROTATION 130-150 WITH LEG POSITIONER. OSTEOSYNTHESIS HAS BEEN PERFORMED WITH INTRAMEDULLARY NAILS ON APRIL 20. THE PATIENT BONE QUALITY IS POOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762702 AMIS 01.15.10.0190 AMIS LEG POSITIONER 2.0 FRAME AMIS LEG POSITIONER LXH MEDACTA INTERNATIONAL SA 01.15.10.0190 1213121A 07630040735773

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Required Intervention