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	Laceration(s) (1946)
Date of Event	07/01/2026
Type of Reportable Event	Other

• 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: 50026001
• Report Number: 3004608878-2026-00081
• Device Sequence Number: 9607294
• Product Code: HBL
• UDI-Device Identifier: 10381780253792
• UDI-Public: 10381780253792
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,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: 07/02/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2017
• 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