BEUDAMED
    FDA Adverse Event Summary report: N

    MAYFIELD HALO CLAMP

    MDR report key: 4253107 · Received October 21, 2014

    Report

    Report Number
    4253107
    Date Received
    October 21, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 21, 2014
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    HBL
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    POSTERIOR CERVICAL FUSION REVISION OF INSTRUMENTATION WITH HALO TRACTION AND USE OF ALLEN C-FLEX POSITIONER. HALO TRACTION WAS PLACED ON FIRST SURGERY. PATIENT WAS TRANSFERRED TO OPEN JACKSON AND POSITIONED INTO HALO C-FLEX FOR SURGERY TO BEGIN. THREE DAYS LATER, PATIENT BACK IN OR FOR ANOTHER SURGERY. DURING THIS SURGERY, DR NEEDED TO REPOSITION THE PATIENT'S NECK AND HEAD. AT THIS POINT, THE BLUE CLAMP THAT SECURES THE HALO TO THE C-FLEX POSITIONER BROKE AND CAUSED THE HEAD TO COME FREE (DR HAD HOLD OF THE HALO SECURING THE HEAD AND NECK). THIS ISSUE NEEDS TO BE RESOLVED: THIS CAUSED A VERY CONCERNING SAFETY ISSUE.SINCE THERE IS NO LIFESPAN ON THE CLAMPS, I HAVE BEEN TRYING TO FIND OUT IF THE MANUFACTURER RECOMMENDS US GETTING NEW CLAMPS SO I CAN CONTACT SURGERY DEPARTMENT TO ORDER MORE. I HAVE ASKED THE QUESTION A COUPLE TIMES AND I AM NOT GETTING A RESPONSE FROM THE MANUFACTURER.======================MANUFACTURER RESPONSE FOR HALO CLAMP THAT ATTACHES TO MAYFIELD, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================LEFT MESSAGE WITH THE QUALITY DEPT AND WAITING TO HEAR BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668982 MAYFIELD HALO CLAMP HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) HBL DEPUY SPINE, INC. 0086 050504

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR NO OTHER THERAPIES| THE OTHER DEVICE DID NOT PLAY A ROLE IN IT.