MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD ULTRA BASE UNIT A2101

Catalog Number	A2101
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that at the beginning of surgery in a patient with sphenoidal meningioma, the intermediary part (transitional member) of the mayfield ultra base unit (a2101) became loose.The patient's head was no longer properly fixed/attached, and the operating position had been changed.There were no other consequence for the patient.However, there could have been a risk/a wrong operating "move" if it would have occurred during surgery.
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.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.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 inspection of the base unit shows that the left bracket is fixated too tight onto the connection tube, the dowel pin which fixates the bracket is deformed and the left bracket must be opened by removing the finishing cap.The dowel pin should be replaced along with the button head screw to restore the function of the moveable bracket, and the end cap needs to be replaced, drilled and pinned to the connecting tube.The 6-inch transitional member has damaged inner thread in the center of its starburst, the golden handle shows rust and must be replaced along with the transferlink and the needed pins, the handle must be adjusted because it is too loose, the shock cushion and cam support pin must be replaced, and the adjustment wrench is missing and must be added to the unit.After completing the reassembly, and the adjustment of the base handle, the unit¿s function must be tested.Root cause - the complaint is confirmed via inspection of the unit.The left bracket was fixed too tightly onto the connecting tube which deformed the dowel pin that secures the bracket, the transitional member had damaged inner threads, and the gold handle had rust.The probable root cause is improper or rough handling of the unit.The a2101 ifu instructs the user to ¿hand tighten adjustment screw on left end bracket until secured¿, and cautions the user: ¿do not over-tighten with adjustment wrench.Adjustment screw can be sufficiently tightened by hand.¿ no further corrective action beyond the repairs is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: MAYFIELD ULTRA BASE UNIT A2101
• 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 ; 6099362319
• MDR Report Key: 24209620
• Report Number: 3004608878-2026-00004
• Device Sequence Number: 14810256
• Product Code: FWZ
• UDI-Device Identifier: 10381780267997
• UDI-Public: 10381780267997
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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
• Device Lot Number: 133691/157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/11/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male