MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD®; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Model Number	A1108
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Mayfield clamp did not torque properly during application.

• Brand Name: MAYFIELD®
• Common Device Name: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 4900 charlemar dr; cincinnati OH 45227
• MDR Report Key: 24741273
• Report Number: 24741273
• Device Sequence Number: 8707826
• Product Code: HBL
• UDI-Device Identifier: 10381780253518
• UDI-Public: (01)10381780253518(11)241210
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/20/2026
• Report Date (Section F): 03/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: A1108
• Device Catalogue Number: A1108
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/31/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/20/2026