BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 4955981 · Received July 29, 2015

    Report

    Report Number
    3004608878-2015-00207
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Report Date
    July 9, 2015
    Manufacturer
    INTEGRA BURLINGTON, MA,INC.
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION (B)(6) 2015. THE INVESTIGATION INCLUDED: METHOD: COMPLAINT TREND. RESULTS: A TWO YEAR LOOK BACK FOR THIS REPORTED FAILURE AND OR RELATED TO "CLAMP DID NOT HOLD THE PINS WELL" FOR THIS PRODUCT FAMILY SHOWS THAT 3 COMPLAINTS WERE RECEIVED INCLUDING THIS CASE. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. CONCLUSION: THE DEVICE WAS NOT RELEASED FOR EVALUATION; THEREFORE, THE ROOT CAUSE TO THE END USERS EXPERIENCE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CLAMP DID NOT HOLD THE PINS WELL. UPON INSPECTION OF THE EQUIPMENT, THE ROCKER ARM DID STRUGGLE TO MAINTAIN THE SKULL PIN IN PLACE. ONCE THE SKULL CLAMP WAS APPLIED, THERE WASN'T AN ISSUE WITH STARTING THE PROCEDURE. THERE PATIENT CONTACT BUT NO PATIENT INJURY. NO REVISION/MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY IN SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495067 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA BURLINGTON, MA,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1