MAUDE Adverse Event Report: Integra LifeSciences Corporation OH/USA MAYFIELD ULTRA BASE UNIT

Catalog Number	A2101
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the mayfield ultra base unit (a2101) would not maintain the head position.The issue was identified at the beginning of the procedure after the patient had been placed under anesthesia.As a result, the surgical procedure was prolonged by more than 30 minutes.No patient injury or adverse clinical outcome was reported.A replacement device was obtained and used to successfully complete the procedure.
Additional Manufacturer Narrative
The mayfield ultra base unit (a2101) was returned for evaluation: device history record (dhr) review- the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the evaluation of the returned unit identified multiple conditions affecting device functionality.The handle was found closed without the transitional member installed, and the handle exhibited slight deformation requiring adjustment.The transitional member was required for proper device testing and closure.The adjustment wrench showed evidence of corrosion and required replacement.The left bracket was excessively tightened to the connection tube, resulting in deformation of the dowel pin securing the bracket.Restoration of bracket mobility required removal of the finishing cap, replacement of the deformed dowel pin and button head screw, and installation of a new end cap.The handle assembly was also found to have a migrated shock cushion that interfered with proper closure of the gold handle.To resolve the issues, the transitional member was replaced and verified for both visual acceptability and proper functionality.The corroded adjustment wrench was replaced.The damaged dowel pin and button head screw were replaced, and the left bracket was reassembled and confirmed to move properly.The connection tube was resealed through installation, drilling, and pinning of a new finishing cap.The handle assembly shock cushion and cam link support pin were replaced, and the handle assembly was reassembled and adjusted to achieve the required pressure on the transitional member.Upon completion of all repairs and adjustments, the device successfully passed functional testing and was verified to perform as intended.Root cause - the complaint is confirmed via the inspection, and the root cause is determined to be user-related misuse resulting in device damage.Specifically, the base handle had been closed without the 6-inch transitional attachment installed, causing the handle opening to become misshapen.A warning label affixed to the base unit instructs users not to close the handle without the transitional attachment inserted.Additionally, the left bracket was overtightened, deforming the dowel pin that holds the bracket in position, and te shock cushion had migrated out of position.No further corrective action beyond these repairs 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.

• Brand Name: MAYFIELD ULTRA BASE UNIT
• 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: 50915625
• Report Number: 3004608878-2026-00106
• Device Sequence Number: 5776957
• Product Code: HBL
• UDI-Device Identifier: 10381780267997
• UDI-Public: 10381780267997
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: A2101
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2015
• 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
• Patient Sex: Unknown