MAUDE Adverse Event Report: Integra LifeSciences Corporation OH/USA Mayfield Composite Series Skull Clamp

Catalog Number	A3059
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	06/24/2026
Type of Reportable Event	Other
Event or Problem Description
A facility reported that the mayfield skull clamp (unknown catalog#) slipped, and the skull pin scraped the patient's skull, causing an injury to the patient.Additional information has been requested.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow up report will be submitted.

• Brand Name: Mayfield Composite Series Skull Clamp
• Common Device Name: Mayfield
• Manufacturer (Section D): Integra LifeSciences Corporation OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): Integra LifeSciences Corporation OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; +1(609)936-2319
• MDR Report Key: 50025485
• Report Number: 3004608878-2026-00079
• Device Sequence Number: 9662547
• Product Code: HBL
• UDI-Device Identifier: 10381780253792
• UDI-Public: 10381780253792
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Pre-Amend
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: Not provided; 08/28/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/21/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown