BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY XR2 SKULL CLAMP

    MDR report key: 21893425 · Received April 23, 2025

    Report

    Report Number
    3004608878-2025-00069
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Report Date
    June 20, 2025
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    UDI-DI
    10381780253761
    PMA / PMN Number
    K130389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H11. THE MAYFIELD INFINITY XR2 CLAMP (A2114) WAS NOT RETURNED, AND NO SPECIFIC DEVICE WAS IDENTIFIED, THEREFORE, FAILURE ANALYSIS CANNOT BE COMPLETED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. ADDITIONALLY, THE LOT/SERIAL NUMBER HAS NOT BEEN PROVIDED TO PERFORM A DEVICE HISTORY RECORD (DHR) REVIEW. AS A RESULT, THE DEFINITE ROOT CAUSE CANNOT BE IDENTIFIED. OF THE CASES REVIEWED, HEAD SLIPPAGE OCCURRED IN 3 OF (B)(4), AND SLIPPAGE IS A KNOWN RISK ASSOCIATED WITH THE USE OF THE MAYFIELD SKULL CLAMPS. BASED ON THE REPORTED COMPLAINT, THE 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

    THERAPEUTICS AND CLINICAL RISK MANAGEMENT (2020:16) PUBLISHED AN ARTICLE TITLED: "ESTIMATION OF RISK FACTORS FOR HEAD SLIPPAGE USING A HEAD CLAMP SYSTEM. A RETROSPECTIVE STUDY" THIS REPORT IS FOR PATIENT #2 OF 3 (MALE, AGE 23, UNDERWENT EPILEPTICAL DISCONNECTION PROCEDURE) AND LINKED TO MFG REPORT NUMBERS 3004608878-2025-00062 AND 3004608878-2025-00070: BACKGROUND: ALTHOUGH COMPLICATIONS HAVE BEEN ASSOCIATED WITH HEAD CLAMP SYSTEMS, FEW REPORTS HAVE DESCRIBED HEAD SLIPPAGE. THE PRESENT STUDY AIMED TO DETERMINE RISK FACTORS FOR HEAD SLIPPAGE AND SPECULATED THAT THE POSITION OF HEAD HOLDER PINS MIGHT BE ASSOCIATED. SUMMARY - IN A PROSPECTIVE, CROSS-SECTIONAL, NONRANDOMIZED STUDY BY SAKAKURA ET AL (2020),16 THE OBJECTIVE OF THE STUDY WAS TO COMPARE THE LOCATION OF PINS PRE- AND POSTOPERATIVELY ON CT IMAGES IN CASES OF HEAD SLIPPAGE. CT IMAGES WERE OBTAINED WITH A RADIOLUCENT CARBON MAYFIELD 3-PIN HEAD HOLDER (INFINITY XR2 RADIOLUCENT SYSTEM). TWENTY-ONE PATIENTS WERE INCLUDED (MEAN AGE AT SURGERY: 21±12.81 YEARS; SEX: 15 MALES, SIX FEMALES). INDICATIONS FOR SURGERY INCLUDED ELECTRODE IMPLANTATION (61.9%), EPILEPTIC FOCUS RESECTION (23.8%), AND EPILEPTIC DISCONNECTION (14.3%). HEAD SLIPPAGE WAS OBSERVED IN THREE PATIENTS (14%). THE CENTER POINT BETWEEN THE MOST CAUDAL PIN AND THE MOST CRANIAL PIN WAS SIGNIFICANTLY ASSOCIATED WITH THE OCCURRENCE OF HEAD SLIPPAGE (P=0.014). THE DISTANCE BETWEEN THE PREOPERATIVE AND POSTOPERATIVE SLIPPED PINS WAS 2.5 MM. THE SLIPPED PINS WERE THE UPPER TWO PINS IN ALL THREE PATIENTS. NO COMPLICATIONS WERE ASSOCIATED WITH HEAD SLIPPAGE. MALFUNCTION - HEAD SLIPPAGE WAS OBSERVED IN THREE PATIENTS (14%). THE CENTER POINT BETWEEN THE MOST CAUDAL PIN AND THE MOST CRANIAL PIN WAS SIGNIFICANTLY ASSOCIATED WITH THE OCCURRENCE OF HEAD SLIPPAGE (P=0.014). THE DISTANCE BETWEEN THE PREOPERATIVE AND POSTOPERATIVE SLIPPED PINS WAS 2.5 MM. THE SLIPPED PINS WERE THE UPPER TWO PINS IN ALL THREE PATIENTS. NO COMPLICATIONS WERE ASSOCIATED WITH HEAD SLIPPAGE. CONCLUSION - CLAMPED HEADS CAN SLIP DURING SURGICAL PROCEDURES. WE FOUND THAT ONE HEAD PIN SHOULD BE LOCATED WITHIN 4.5 CM FROM THE NASION-INION (NI) LINE TO AVOID HEAD SLIPPAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271980 MAYFIELD INFINITY XR2 SKULL CLAMP MAYFIELD HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 10381780253761

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male