MAUDE Adverse Event Report: Integra LifeSciences Corporation OH/USA MAYFIELD® 2 Base Unit, Standard

Catalog Number	A3101
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
This is 1 of 2 reports linked to mfg report number (b)(4): a facility reported that the mayfield 2 base unit, standard (a3101) became loose during a procedure.Additional information has been requested.
Additional Manufacturer Narrative
The mayfield composite series base unit, standard (a3101) was returned for evaluation: device history record (dhr) review - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - inspection of the mayfield base unit a3101 ((b)(6)) determined that the screw on the standard adapter a3018 exhibited damaged threads and could not be properly threaded into the knob of the connecting element.The damaged screw on the standard adapter a3018 was replaced, restoring proper engagement with the connecting element knob.Following completion of the repair, the device underwent functional testing and successfully met all applicable performance requirements.Root cause - the complaint is confirmed via inspection of the unit.The screw on the a3018 adapter had damaged threads and could not be screwed into the knob of the transitional (connecting element).The probable root cause is damage from mishandling of the unit.Additionally, improper or suboptimal placement of the mayfield system can contribute to movement of the unit or patient.Based on the evaluation of the event, no further investigation 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.

• Brand Name: MAYFIELD® 2 Base Unit, Standard
• 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: 50916231
• Report Number: 3004608878-2026-00107
• Device Sequence Number: 5370271
• Product Code: FWZ
• UDI-Device Identifier: 10381780268161
• UDI-Public: 10381780268161
• 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: A3101
• Date Returned to Manufacturer: 09/14/2026
• 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: 09/04/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Mayfield Composite Series Skull Clamp (A3059)
• Patient Sex: Unknown