BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 22549466 · Received July 18, 2025

    Report

    Report Number
    3004608878-2025-00147
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 23, 2025
    Report Date
    July 18, 2025
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    UDI-DI
    10381780253457
    PMA / PMN Number
    PRE-AMEND
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MAYFIELD MODIFIED SKULL CLAMP (A1059) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - THE DHR WAS REVIEWED AND SHOWS NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. FAILURE ANALYSIS - THE CUSTOMER'S STATEMENT WAS CONFIRMED AS VALID AFTER EVALUATING THE DEVICE. THE INSPECTION OF THE SKULL CLAMP (SN: (B)(6) SHOWS THE SKULL CLAMP HAS A STICKING SWIVEL LOCK ASSEMBLY, AND UPON OPENING THE MECHANISM, IT SHOWS DIRT AND LIMESCALE INSIDE. TO RESOLVE THE ISSUES FOUND, THE LOCK WAS CLEANED, GREASED AND ADJUSTED. THE UNIT HAS BEEN SUBJECTED TO A SUCCESSFUL FUNCTIONAL CHECK TO MEET THE MANUFACTURER'S SPECIFICATIONS. THIS REPAIR IS PERFORMED AS A GOODWILL GESTURE AND WILL NOT BE CHARGED TO THE CUSTOMER; NO SPARE PARTS ARE REQUIRED, AS THE UNIT WAS SERVICED IN APRIL 2025. ROOT CAUSE - THE COMPLAINT IS CONFIRMED VIA INSPECTION OF THE UNIT. THE UNIT NEEDED TO BE CLEANED, GREASED, AND ADJUSTED. THE PROBABLE ROOT CAUSE IS ROUTINE WEAR AND IMPROPER CLEANING. NO CORRECTIVE ACTION HAS BEEN INITIATED FOR THE SAME OR SIMILAR ISSUE. THIS WILL BE MONITORED AND TRENDED GOING FORWARD. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    THIS REPORT IS FOR PATIENT 2. REFER TO MFG REPORT #3004608878-2025-00146 FOR REPORT ON PATIENT#1. A FACILITY REPORTED THEY EXPERIENCED DIFFICULTY TO CLOSE/LOCK THE MAYFIELD MODIFIED SKULL CLAMP ON A PATIENT: THE CLAMPING SCREW FAILED TO PROVIDE SAFETY AND THE TIP BECAME EMBEDDED IN THE PATIENT'S SKULL. THE DEVICE HAD TO BE REPLACED. LESS THAN 30 MINUTES OF TIME WAS LOST. THE CLAMP DID NOT REACT TO PRESSURE, THE PIN SANK INTO THE PATIENT'S HEAD. USUALLY THE PRESSION INDICATOR (TORQUE SCREW) GOES OUT, BUT IN THIS CASE IT DID NOT. CONSEQUENCES: WOUNDS OF PATIENT SCALP + TIME OF SURGERY INCREASE. INFECTIOUS RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295166 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 10381780253457

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other