BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG STRUT TI-HEX - 158MM-318MM

    MDR report key: 4718161 · Received April 16, 2015

    Report

    Report Number
    9680825-2015-00010
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Date of Event
    August 20, 2014
    Report Date
    April 13, 2015
    Manufacturer
    ORTHOFIX SRL
    Product Code
    KTT
    PMA / PMN Number
    K141078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: THE DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RECEIVED BY ORTHOFIX SRL. UNFORTUNATELY ALSO THE CODE AND LOT NUMBER HAVE NOT BEEN MADE AVAILABLE AND CONFIRMED. THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVAL: A TECHNICAL EVAL OF THE DEVICE IS NOT POSSIBLE AS THE DEVICE WAS NOT RETURNED TO ORTHOFIX SRL. MEDICAL EVAL: THE LITTLE INFO MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVAL. A PRELIMINARY MEDICAL EVAL IS CURRENTLY ON GOING AND WILL BE FINALIZED ONCE FURTHER INFO ON THE CASE WILL BE AVAILABLE. ORTHOFIX SRL HAS REQUESTED FURTHER INFO ON THE EVENT, SUCH AS CONFIRMATION OF CODE AND LOT NUMBER OF THE DEVICE INVOLVED, DATE OF INITIAL SURGERY AND DATE OF DEVICE FAILURE, PT'S INFO, SURGERY DESCRIPTION, COPIES OF X-RAY IMAGES, REMEDIAL ACTION TAKEN FOLLOWING THE DEVICE FAILURE, PT'S CURRENT HEALTH CONDITIONS. AS SOON AS FURTHER INFO WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A F/U REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET,

    Description of Event or Problem · 1

    THE INFO PROVIDED BY THE TOTAL DISTRIBUTOR INDICATES: HOSPITAL NAME: IMPERIAL COLLEGE HEALTHCARE NHS TRUST; SURGEON NAME: MR. (B)(6); EVENT DESCRIPTION: BROKEN STRUT IN A PT. UNFORTUNATELY DON'T KNOW WHERE THE TIME IS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252911 LONG STRUT TI-HEX - 158MM-318MM LONG STRUT TI-HEX - 158MM-318MM KTT ORTHOFIX SRL 50-10400 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1