BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD COMPOSITE SERIES SKULL CLAMP

    MDR report key: 19350905 · Received May 20, 2024

    Report

    Report Number
    3004608878-2024-00063
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    May 1, 2024
    Report Date
    June 11, 2024
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    UDI-DI
    10381780253792
    PMA / PMN Number
    K142238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B1, G3, G6, H2, H3, H11. ADDITIONAL INFORMATION RECEIVED FROM FACILITY'S BIOMEDICAL ENGINEER AS FOLLOWS: "THIS SKULL CLAMP JUST NEEDS TO BE RESURFACED AND AN END CAP REPLACED. 1. WHAT IS THE DATE OF THE INCIDENT? (B)(6) 2024. 2. WAS THERE A DELAY IN SURGERY DUE TO THE PRODUCT PROBLEM? NO. (A) IF YES, HOW LONG IN MINUTES? NA. 3. WAS THERE PATIENT INJURY? NO. 4. WAS ANY MEDICAL/SURGICAL INTERVENTION PERFORMED? NO. 5. HOW WAS THE PROCEDURE COMPLETED? USING ANOTHER SKULL CLAMP. 6. PLEASE PROVIDE PATIENT OUTCOME. SUCCESSFUL. 7. PLEASE PROVIDE PATIENT INFORMATION: UNAVAILABLE. A. DATE OF BIRTH: NA. B. AGE: NA. C. GENDER: NA. D. WEIGHT: NA. E. ETHNICITY (HISPANIC/LATINO, NOT HISPANIC/LATINO): NA F. RACE (ASIAN, AMERICAN INDIAN OR ALASKAN NATIVE, BLACK. OR AFRICAN AMERICAN, WHITE, NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER): NA ".

    Additional Manufacturer Narrative · 0

    CORRECTED FIELDS: B3 (DATE OF EVENT SUBMITTED IN FOLLOW-UP MDR #1 IS INCORRECT), H11 (SEE CORRECTED NARRATIVE BELOW WHICH SUPERSEDES NARRATIVE SUBMITTED IN FOLLOW-UP MDR #1). ADDITIONAL INFORMATION RECEIVED FROM FACILITY'S BIOMEDICAL ENGINEER AS FOLLOWS: 1. WAS THERE A DELAY IN SURGERY DUE TO THE PRODUCT PROBLEM? >> NO. (A) IF YES, HOW LONG IN MINUTES? >> NA. 2. WAS THERE PATIENT INJURY? >> NO. 3. WAS ANY MEDICAL/SURGICAL INTERVENTION PERFORMED? >> NO. 4. HOW WAS THE PROCEDURE COMPLETED? >> USING ANOTHER SKULL CLAMP. 5. PLEASE PROVIDE PATIENT OUTCOME. >> SUCCESSFUL. 6. PLEASE PROVIDE PATIENT INFORMATION: >> UNAVAILABLE. A. DATE OF BIRTH: >> NA. B. AGE: >> NA. C. GENDER: >> NA. D. WEIGHT: >> NA. E. ETHNICITY (HISPANIC/LATINO, NOT HISPANIC/LATINO): >> NA. F. RACE (ASIAN, AMERICAN INDIAN OR ALASKAN NATIVE, BLACK OR AFRICAN AMERICAN, WHITE, NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER): >> NA ".

    Additional Manufacturer Narrative · 0

    THE MAYFIELD SKULL CLAMP (A3059) WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - THE DHR WAS REVIEWED AND SHOWS NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. FAILURE ANALYSIS - THE INVESTIGATION OF THE RETURNED DEVICE WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE DEVICE PASSED ALL SPECIFIC FUNCTIONAL TESTING, AND WHEN PROPERLY POSITIONED AND PUT UNDER PRESSURE IT DID NOT MOVE. THE UNIT WAS PLACED UNDER PRESSURE, ROTATED MANY TIMES AND IT LOCKED EVERY TIME. ROOT CAUSE - EVALUATION FOUND NO DEVICE DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. PROBABLE ROOT CAUSE IS IMPROPER OR SUBOPTIMAL POSITIONING OF THE SKULL CLAMP ON THE PATIENT. NO FURTHER INVESTIGATION IS REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT THE LOCKING MECHANISM ON THE MAYFIELD COMPOSITE SERIES SKULL CLAMP (A3059) WOULD NOT FULLY ENGAGE PRIOR TO AND DURING THE CASE. THE SURGEON HAD TO BREAK SCRUB TO REPOSITION THE PATIENT'S HEAD AFTER MOVEMENT. THERE WAS NO PATIENT INJURY, AND NO KNOWN DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872680 MAYFIELD COMPOSITE SERIES SKULL CLAMP COMPOSITE SERIES HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 10381780253792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown