BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALUX PYRAMID C6 27CM RIGHT

    MDR report key: 6509127 · Received April 20, 2017

    Report

    Report Number
    3003764610-2017-00002
    Event Type
    Injury
    Date Received
    April 20, 2017
    Date of Event
    April 2, 2017
    Report Date
    April 20, 2017
    Manufacturer
    OSSUR H/F
    Product Code
    ISH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AMPUTEE (B)(6) YEAR OLD PATIENT WALKS WITH A CANE, WHILE WALKING, CLAIMS THE FOOT BROKE JUST BELOW THE PYRAMID CAUSING THE PATIENT TO FALL. THE PATIENT SOUGHT MEDICAL TREATMENT AND SUSTAINED A BROKEN HIP WHICH REQUIRED SURGERY. PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

    Description of Event or Problem · 1

    AMPUTEE (B)(6) YEAR OLD PATIENT WALKS WITH A CANE, WHILE WALKING, CLAIMS THE FOOT BROKE JUST BELOW THE PYRAMID CAUSING THE PATIENT TO FALL. THE PATIENT SOUGHT MEDICAL TREATMENT AND SUSTAINED A BROKEN HIP WHICH REQUIRED SURGERY. PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288216 TALUX PYRAMID C6 27CM RIGHT COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT ISH OSSUR H/F TLP0627R

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R