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	Abrasion (1689)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
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 inspection of the mayfield base unit a2101 with serial number: (b)(6) shows no defects.The internal thread of the transitional member is in good condition and screws perfectly into the included swivel adapter.The handle is not deformed and the transitional member fits perfectly into the handle.The handle closes properly and provides a secure grip once closed so that the transitional member has no movement.The left bracket is adjustable, and the shock cushion is in place.However, unrelated to the complaint issue reported, the adjusting wrench thread is broken, and the wrench needs to be replaced.It is to be noted that the unit must first be adjusted, then closed, and not adjusted again after closing.It is also important to ensure that the unit is firmly attached to the operating table and does not wobble, and it is also essential to ensure that the transitional member and the teeth of the swivel adapter do not collide.The adjustment wrench was replaced and the unit was subjected to a successful functional check and meets manufacturer specifications.Root cause - the complaint is not confirmed via inspection since the base unit showed no defects.The probable root cause is improper or suboptimal placement/setup of the mayfield system.No further corrective action 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.
Event or Problem Description
This is 2 of 3 reports linked to mfg report numbers: 3004608878-2026-00007 and 3004608878-2026-00031: a facility reported that the mayfield ultra base unit (a2101) came loose during surgery, resulting in a single scratch to the patient's hairline/forehead, and a bandage was applied to the forehead.Another device was used to complete the surgery.The surgery time was not significantly increased.

• 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: 24599763
• Report Number: 3004608878-2026-00030
• Device Sequence Number: 13138457
• 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
• Report Date (Section B): 03/13/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A2101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown