BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MAYFIELD SKULL CLAMP

    MDR report key: 15955784 · Received December 9, 2022

    Report

    Report Number
    3004608878-2022-00264
    Event Type
    Injury
    Date Received
    December 9, 2022
    Date of Event
    May 23, 2022
    Report Date
    February 3, 2023
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    PRE-AMEND
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    MAYFIELD SKULL CLAMP WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE DEFINITE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, BASED ON THE REPORTED COMPLAINT, PROBABLE ROOT CAUSE IS IMPROPER OR SUBOPTIMAL PLACEMENT OF THE SKULL CLAMP ON THE PATIENT. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT WHEN THE SURGEON WAS LOGROLLING THE PATIENT ONTO THE TRIOS TABLE AND CONNECTING MAYFIELD (PRODUCT ID IS UNKNOWN) TO THE COUPLER 2, THE MAYFIELD MOVED AND CAUSED A CUT/LACERATION TO THE PATIENT'S HEAD FROM THE MAYFIELD PIN SLIDING ON THE HEAD. NO SURGERY DELAY HAS BEEN REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2544237 UNKNOWN MAYFIELD SKULL CLAMP SKULLCLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown