BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD RADIOLUCENT BASE UNIT W/ADAPTORS

    MDR report key: 4679800 · Received April 8, 2015

    Report

    Report Number
    3004608878-2015-00118
    Event Type
    Injury
    Date Received
    April 8, 2015
    Date of Event
    March 4, 2015
    Report Date
    March 12, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    IT WAS INITIALLY REPORTED THAT A PATIENT "WAS LOSING SIGNAL" WHILE IN CONTACT WITH AN A1079. IT WAS FURTHER EXPLAINED BY THE ASSOCIATED NURSE MGR THAT THIS PATIENT LOST SENSORY AND MOTOR FUNCTION OF HIS "GOOD LEG" FOLLOWING MOVEMENT OF THE BASE UNIT. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2015 WAS AS FOLLOWS: THE PATIENT HAS A BELOW THE KNEE AMPUTATION AND WAS INITIALLY PRONE WHEN THE BASE UNIT MOVED. THE LOSS OF SENSORY MOTOR FUNCTION APPEARED TO BE TEMPORARY, BUT BECAUSE THE NURSE WAS NOT PRESENT IN THE OPERATING ROOM WHEN THE EVENT OCCURRED, SHE WAS UNCERTAIN AS TO WHETHER HE REGAINED FULL SENSORY MOTOR FUNCTION BACK TO BASELINE. MAYFIELD SKULL PINS (A1072 LOT # 1132631) WERE USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231993 MAYFIELD RADIOLUCENT BASE UNIT W/ADAPTORS NONE HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other