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

Catalog Number	A2101
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This is 1 of 3 reports linked to mfg report numbers 3004608878-2026-00026 and 3004608878-2026-00027: a facility reported that the mayfield ultra base unit (a2101) was part of a cervical stabilization case where the physician stated that the entire system felt like it slipped.The procedure was completed per usual with no injury to the patient, who is recovering as expected.Additionally, there was no surgical delay.
Additional Manufacturer Narrative
The mayfield ultra base unit (a2101) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the evaluation of the returned unit shows that the shock cushion has moved forward in handle and is impeding the 6in transitional from going into handle.The 6in transitional has worn teeth, the shock cushion and 1/4in pin are worn, and the adjustment wrench has worn threads.Additionally, the unit was purchased in 2019 and has no service record; therefore, it is recommended that the unit receive a preventive maintenance (pm) service.To resolve the issues, the adjustment screw, finishing cap, adjustment wrench, 1/4 pin, 6in transitional, isolator lock pins, shock cushion, labels and roll pin will be replaced with general maintenance and cleaning.Root cause - complaint confirmed via inspection of the unit.The unit has worn teeth on the 6in transitional, the swivel adapter has worn teeth on the swivel sleeve, and it was not able to properly mesh up with the teeth on the transitional.Unit was purchased in 2019 and has no service record; therefore, it is recommended that the unit receive a pm service.The probable root cause is routine wear and lack of proper maintenance.No further corrective action is required beyond the repairs 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 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: 24549058
• Report Number: 3004608878-2026-00025
• Device Sequence Number: 9404509
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MAYFIELD MODIFIED SKULL CLAMP (A1059); MAYFIELD SWIVEL ADAPTOR (A1018)
• Patient Sex: Unknown