BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEQUALIS HUMERAL BROACH 6.5 MM

    MDR report key: 2322009 · Received October 18, 2011

    Report

    Report Number
    9610667-2011-00026
    Event Type
    Malfunction
    Date Received
    October 18, 2011
    Date of Event
    January 12, 2010
    Report Date
    March 4, 2010
    Manufacturer
    TORNIER INC.
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEWED. DEVICE HISTORY RECORDS SHOW PRODUCT WAS MADE TO SPECIFICATION. VISUAL INSPECTION SHOWS RUPTURE AT THE FOURTH TOOTH. TORNIER INC. IS SUBMITTING THIS MEDICAL DEVICE REPORT AS A RESULT OF A PROACTIVE REVIEW OF VIGILANCE EVENTS REPORTED TO (B)(4) OR TO OTHER COMPETENT AUTHORITIES IN (B)(4) DURING 2009 AND 2010. THE EVENTS DESCRIBED IN THIS MEDICAL DEVICE REPORT OCCURRED OUTSIDE OF THE UNITED STATES. THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    BROACH BROKE DURING USE. A SEGMENT OF THE BROACH REMAINS IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEQUALIS HUMERAL BROACH 6.5 MM HUMERAL BROACH HTQ TORNIER INC. 05B337

    Patients

    Seq Age Sex Outcome Treatment
    1