BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSVII, CONNECTOR WITH ANTECHAMBER

    MDR report key: 2406344 · Received December 9, 2011

    Report

    Report Number
    9612007-2011-00053
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Date of Event
    September 13, 2011
    Report Date
    December 9, 2011
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFE SCIENCES ENGINEERS PROVIDED INFO BASED ON THE REPORTED EVENT - THE OSVII DID NOT FUNCTION DURING SURGERY. THE COMPLAINT WAS UNVERIFIABLE AND ITS EXACT CAUSE COULD NOT BE DETERMINED. WITHOUT THE ACTUAL DEVICE TO EVALUATE AND BASED ON THE PROVIDED INFO, NO FURTHER INVESTIGATION NOR CORRECTIVE ACTION IS DEEMED REQUIRED. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED ON (B)(6) 2011 FOR AN OSVII UPGRADED THIS REPORT TO A MDR. THE REPORTED INFO WAS AS FOLLOWS "IT DIDN'T WORK DURING AN OPERATION PERFORMED (B)(6) 2011." THE PT DID NOT INCUR AN INJURY AS A RESULT OF THIS EVENT. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSVII, CONNECTOR WITH ANTECHAMBER NA JXG INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1