BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 5346653 · Received January 6, 2016

    Report

    Report Number
    3004608878-2016-00001
    Event Type
    Injury
    Date Received
    January 6, 2016
    Date of Event
    December 11, 2015
    Report Date
    December 15, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 22 FEB 2016. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINT HISTORY. RESULTS: EVALUATION OF DEVICE: BASED ON THE EXAMINATION OF THE DEVICE, ENGINEERING AND REPAIRS WERE NOT ABLE TO CONFIRM THE CUSTOMER COMPLAINT. NO SLIPPAGES WERE FOUND WHEN THE UNIT WAS SUBMITTED TO THE BLOCK TEST. THE DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID LOT CODE: 104 / MANUFACTURED: 30 JUN 2010 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THIS DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S OR VARIANCES. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. CONCLUSION: THE CUSTOMER COMPLAINT INCIDENT COULD NOT BE CONFIRMED. ALL THE MEASUREMENTS WERE WITHIN THE TOLERANCES SPECIFIED. INTEGRA LIFE SCIENCES RECOMMENDS ITS PRODUCTS TO BE SENT IN FOR ROUTINE MAINTENANCE ONCE A YEAR. THIS ISSUE WILL BE MONITORED FOR TRENDING.

    Description of Event or Problem · 1

    THE A1059 MAYFIELD CLAMP SLIPPED DURING A POSTERIOR CERVICAL FORAMINOTOMY/MICRODISCECTOMY PROCEDURE CASE ON (B)(6) 2015. THE PATIENT WAS POSITIONED PRONE WITH THE MAYFIELD HEAD REST AND PINS. WHEN THE CLAMP WAS FIXED, THE HEAD SLIPPED FROM THE PINS CAUSING A 4CM LACERATION TO THE TEMPORAL AREA. THE PATIENT WAS THEN PUT BACK ON THE PATIENT'S BED AND THE LACERATION WAS SUTURED. THE SURGEON PROCEEDED WITH THE OPERATION. THE ESTIMATED TIME OF DELAY WAS 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8030 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention