BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HFD100 HEAD FIXATION DEVICE

    MDR report key: 6202824 · Received December 23, 2016

    Report

    Report Number
    3010326005-2016-00006
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    November 7, 2016
    Report Date
    January 26, 2017
    Manufacturer
    IMRIS-DEERFIELD IMAGING, INC.
    Product Code
    HBL
    UDI-DI
    00857534006011
    PMA / PMN Number
    K103493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HFD100 SKULL CLAMP ASSEMBLY HAS NOT YET BEEN RETURNED FROM THE CUSTOMER FOR EVALUATION. ONCE THE DEVICE IS RECEIVED, IT SHALL BE EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT TO FDA.

    Additional Manufacturer Narrative · 1

    THE INITIAL ADVERSE EVENT REPORT WAS SUBMITTED TO FDA ON 12/23/2016. ONCE THE SKULL CLAMP IN QUESTION WAS RECEIVED, IT WAS EVALUATED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. A MECHANICAL EVALUATION OF THE SKULL CLAMP WAS PERFORMED AND THE DEVICE WAS FOUND TO BE OPERATING WITHIN SPECIFICATIONS. WE WERE UNABLE TO VERIFY THE COMPLAINT. THE FACT THAT THE THREE SURGEONS VERIFIED THAT ALL POINTS ON THE HFD WERE TIGHT AND SECURE AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT SUPPORTS A CONCLUSION THAT THERE WAS NO DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THREE NEUROSURGEONS WERE PERFORMING A TUMOR RESECTION ON A (B)(6) BOY. AT ONE POINT IN THE PROCEDURE, THE SURGEONS THOUGHT THEY FELT THE PATIENT'S HEAD SHIFT DUE TO MOVEMENT ON THE DOUBLE-PIN SIDE OF THE HFD100 FIXATION DEVICE. THE SURGEONS WORKED TOGETHER TO VERIFY THAT ALL POINTS WERE TIGHT AND SECURE ON THE HFD, THEN CONTINUED WITH THE CASE. THERE WAS NO INJURY OR ADVERSE EFFECT TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FULL RESECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THREE NEUROSURGEONS WERE PERFORMING A TUMOR RESECTION ON A (B)(6) YEAR OLD PATIENT. AT ONE POINT IN THE PROCEDURE, THE SURGEONS THOUGHT THEY FELT THE PATIENT'S HEAD SHIFT DUE TO MOVEMENT ON THE DOUBLE-PIN SIDE OF THE HFD100 HEAD FIXATION DEVICE. THE SURGEONS WORKED TOGETHER TO VERIFY THAT ALL POINTS WERE TIGHT AND SECURE ON THE HFD, THEN CONTINUED WITH THE CASE. THERE WAS NO INJURY OR ADVERSE EFFECT TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FULL RESECTION. AT THE TIME THAT THE ORIGINAL MDR WAS SUBMITTED (12/23/2016), THE HEAD FIXATION DEVICE HAD NOT BEEN RETURNED FOR EVALUATION. THIS FOLLOW-UP REPORT PROVIDES THE RESULTS OF EVALUATION OF THE RETURNED HFD SKULL CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853033 HFD100 HEAD FIXATION DEVICE SKULL CLAMP HBL IMRIS-DEERFIELD IMAGING, INC. 113802-000 N/A 00857534006011

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Life Threatening