BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 16526985 · Received March 10, 2023

    Report

    Report Number
    3004608878-2023-00034
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    September 19, 2022
    Report Date
    May 5, 2023
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    UDI-DI
    10381780253457
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H10. THE MAYFIELD MODIFIED SKULL CLAMP (A1059) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AND FOUND NO ANOMALIES. THE DEFINITE ROOT CAUSE CANNOT BE IDENTIFIED AS THE DEVICE WAS NOT RETURNED; 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A NURSE REPORTED THAT THE PATIENT SLIPPED IN THE MAYFIELD PINS WHILE THE SURGEON WAS DOING A POSTERIOR CERVICAL FUSION. THE MAYFIELD MODIFIED SKULL CLAMP (A1059) WAS ATTACHED TO THE LEVO DURING THE CASE. PATIENT WAS INITIALLY POSITIONED PRONE ON OPEN TRIOS TABLE, NO REPOSITIONING DONE. THE UNIT WAS USED FOR APPROXIMATELY TWO HOURS BEFORE THE EVENT OCCURRED. THERE WAS NO PATIENT INJURY AND NO SIGNIFICANT DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472965 MAYFIELD MODIFIED SKULL CLAMP N/A HBL INTEGRA LIFESCIENCES CORPORATION OH/USA A1059 10381780253457

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male