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

Catalog Number	A2101
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
This is 1 of 4 reports linked to mfg report numbers and is for the first ultra base unit used: 3004608878-2025-00234, 3004608878-2025-00236, 3004608878-2025-00237.A facility reported that the terminal was not clamping properly and springs open; has to be forced shut, cannot be opened on its own and is getting progressively worse.A second mayfield was used to finish the surgery, but the same problem occurred.The patient was under anesthesia, and the device was in contact with the patient; however, no harm resulted.The issue occurred prior to the surgery, and surgical delay was less than 30 minutes.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field: d4, d9, g3, g6, h2, h3, h6, h11.The mayfield ultra base unit (a2101) was returned for evaluation: failure analysis- inspection of the returned unit reveals that the handle does not close properly and requires repair.The base casting is found to have deep scratches on the inside, and these are damaging the connecting element and preventing a secure hold.The base casting must be replaced along with the necessary pins, the shock cushion is worn and needs to be replaced.To remove the handle, the left bracket must be opened, the pin replaced, and the end cap re-drilled.The 6-inch transition element has deep scratches on the running surface on the underside and must be replaced to prevent damage and impairment of the handle unit's function.Also, the pin on the right bracket is broken and the adjustment key is rusty and must be replaced.Additionally, the unit is to be marked with 2185608, and after reassembly and adjustment of the base handle, the unit's function must be tested.Root cause - the complaint is confirmed via inspection of the unit.The handle of the base unit did not close properly, the base casting had deep scratches on the inside that were damaging the connecting element.The transitional had deep scratches as well, and the pin on the right bracket was broken.The probable root cause is rough or improper handling of the unit.No further corrective action beyond the necessary 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 ; 6099362319
• MDR Report Key: 23796702
• Report Number: 3004608878-2025-00233
• Device Sequence Number: 5546614
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: A1059 MAYFIELD MODIFIED SKULL CLAMP
• Patient Sex: Unknown