BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAD RING DRIVE EXTEND/SHORT

    MDR report key: 4260816 · Received November 14, 2014

    Report

    Report Number
    1222895-2014-00031
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 21, 2014
    Manufacturer
    INTEGRA BURLINGTON MA, INC.
    Product Code
    HAW
    PMA / PMN Number
    K944463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THE HEADRING DRIVE EXTENSIONS WERE NOT BRAISED/SOLDERED COMPLETELY THROUGH THE TWO LAYERS OF METAL, ONLY ON THE SURROUND OF THE METAL, WHICH MEANT THAN WHEN SCREWED INTO THE PATIENTS HEAD, THEY BENT. INCOMPLETE BRAZING CAUSING THE METAL PLATES TO SEPARATE. THE FOUR DRIVE POST SUBSEQUENTLY BENT. THE PROBLEM OCCURRED DURING INTUBATION HEAD RING FIXATION FOR A STEREOTACTIC RADIOSURGERY CASE. THERE WAS A 30-40 MINUTE SURGICAL DELAY. THERE WAS PATIENT CONTACT. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS RECEIVED (B)(6) 2014: THE PROBLEM OCCURRED DURING A STEREOTACTIC RADIOSURGERY ON AN ADULT FEMALE WHO REQUIRED THE PROCEDURE DUE TO ARTERIOVENOUS MALFORMATION OF CEREBRAL VESSELS ON (B)(6) 2014. THE SURGICAL DELAY REPORTED WAS CAUSED BY THE BENDING OF THE PRODUCT WHEN IT WAS SCREWED INTO THE PATIENT'S HEAD. THE PATIENT WAS AWAKE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738858 HEAD RING DRIVE EXTEND/SHORT NA HAW INTEGRA BURLINGTON MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1