BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWIVEL ADAPTOR

    MDR report key: 2540850 · Received March 16, 2009

    Report

    Report Number
    3004608878-2009-00086
    Event Type
    Malfunction
    Date Received
    March 16, 2009
    Report Date
    March 16, 2009
    Manufacturer
    INTEGRA-OHIO, INC.
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 WILL BE INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    INTEGRA LIFESCIENCES CORP RECEIVED THE FOLLOWING INFO FROM A VOLUNTARY MEDWATCH FORM: "THE MAYFIELD SWIVEL ADAPTOR (PRODUCT # A1018) BROKE OFF". ADD'L INFO WAS RECEIVED FROM THE FACILITY ON (B)(6) 2009. IT WAS REPORTED THAT THE DEVICE SNAPPED (BROKE) OFF AT THE BASE. THE PT'S HEAD SLIPPED BUT A MEMBER OF THE SURGICAL TEAM WAS ABLE TO CATCH AND STABILIZE THE HEAD; AND THERE WAS NO PT INJURY. THE DEVICE IS CURRENTLY WITH RISK MGMT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIVEL ADAPTOR NA HBL INTEGRA-OHIO, INC. 064

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention