BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUDDE HALO RETRACTOR

    MDR report key: 3871262 · Received April 15, 2014

    Report

    Report Number
    3004608878-2014-00038
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Report Date
    March 14, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE COMPONENTS OF THE A1040 (BUDDE HALO RETRACTOR) HAD ISSUES FOUND AT INCOMING INSPECTION BY THE DISTRIBUTOR. THERE WAS NO PT CONTACT OR PT INJURY. THE 438B1178 (CONTINU TRAC HALO RING) = PARTS WERE NOT ATTACHED AT A MOVING PART. THE 438A1024 (HALO ADJUSTMENT WRENCH) = WIRE WAS CUT. THE 438B1010 (HALO SUPPORT BRACKET) = DID NOT INCLUDE A SPRING, AND THE MOVEMENT WAS NOT SMOOTH. THE 438A1077X (BUDDE CURVED RETRACTOR) = THE JOINT PART WAS NOT ATTACHED STRAIGHTLY TO THE MAIN BODY, AND THE AXIS WAS DEVIATED. THE 438A1011 (HALO FLEX ARM) = RING MOUNTING AREA HAS A HOLE. THE 438A1037 (HALO PATTIE TRAY) = DENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230636 BUDDE HALO RETRACTOR NA GZT INTEGRA LIFESCIENCES CORPORATION OH/USA 131

    Patients

    Seq Age Sex Outcome Treatment
    1