BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUDDE HALO RETRACTOR

    MDR report key: 3928503 · Received June 9, 2014

    Report

    Report Number
    3004608878-2014-00079
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    May 15, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GZT
    PMA / PMN Number
    K830332
    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 EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, COMPONENTS OF THE A1040 (BUDDE HALO RETRACTOR) HAD ISSUES FOUND AT INCOMING INSPECTION OF GOODS BY THE DISTRIBUTOR. THERE WAS NO PATIENT CONTACT OR PATIENT INJURY. (ADJUSTMENT WRENCH ASSEMBLY) (B)(4); THE WIRE WAS DISCONNECTED (CONTINUTRAC HALO RING) (B)(4); THE PARTS OF BOTH SIDE SURFACES WERE NOT ATTACHED. (9 INCH RETRACTOR ARM ASSEMBLY) (B)(4); THE TIP PART WAS NOT COMPLETELY FIXED; IT MAY MOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335048 BUDDE HALO RETRACTOR NA GZT INTEGRA LIFESCIENCES CORPORATION OH/USA 139

    Patients

    Seq Age Sex Outcome Treatment
    1 SUPPORT BRACKET ASSEMBLY: (B)(4)| 1/4 X 4 INCH RETRACTOR ASSEMBLY: (B)(4)