BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLASSIC II VEST LGE-INTERNATIONAL

    MDR report key: 3299968 · Received August 21, 2013

    Report

    Report Number
    1526439-2013-24627
    Event Type
    Malfunction
    Date Received
    August 21, 2013
    Date of Event
    July 16, 2013
    Report Date
    August 8, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    IQF
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED KNOB FOR THE CLASSIC II VEST NOTED THAT THE THREADED FEATURE WAS FRACTURED. NO OTHER VISUAL ANOMALIES WERE NOTED DURING THE DEVICE EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. REVIEW OF PRODUCT COMPLAINTS FOUND NO EMERGING TRENDS. THE ROOT CAUSE OF THE KNOB FAILURE IS UNKNOWN. HOWEVER, THE KNOB MAY HAVE BEEN SUBJECTED TO AN UNANTICIPATED LEVEL OF STRESS RESULTING IN FRACTURE. NO CORRECTIVE ACTION IS REQUIRED AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE AND THERE HAS BEEN NO OBSERVED SYSTEMIC TREND. THEREFORE, THE COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT A POSTERIOR LOCKING KNOB ON THE CLASSIC II HALO VEST PROCEDURE SET WAS BROKEN WHILE THE PATIENT WAS LYING IN BED, RESULTING IN INSTABILITY OF THE HALO SYSTEM. A KNOB TAKEN FROM ANOTHER VEST AT THE HOSPITAL WAS USED IN ITS PLACE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404840 CLASSIC II VEST LGE-INTERNATIONAL ORTHOSIS, CERVICAL-THORACIC, RIGID IQF DEPUY SYNTHES SPINE 057954

    Patients

    Seq Age Sex Outcome Treatment
    1