MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD ULTRA BASE UNIT; BASE UNITS AND ADAPTERS

Catalog Number	A2101
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Neck Stiffness (2434)
Type of Reportable Event	Serious Injury
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 4 of 4 reports for the mayfield system linked to mfg report numbers: 3004608878-2025-00148, 3004608878-2025-00149, 3004608878-2025-00151.A facility reported that the mayfield ultra base unit (a2101) needs to be checked as it got loose/became unlocked during surgery, resulting in whiplash for the patient.It is unclear if the event led to increased surgery time.No further information is available.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The mayfield 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 shows the handle cannot be closed properly, and the cam support pin is broken and needs to be replaced along with the worn shock cushion.The cam rod and set screw show rust, so for this reason, the cam rod cannot function properly.To resolve the issues, the base handle assembly¿s shock cushion and its cam link support pin were replaced.The handle assembly was reassembled and adjusted to build up the required pressure onto the transitional member.After completing the repair, the unit successfully passed a function test.Root cause - the complaint is confirmed via inspection of the unit.The handle could not be closed properly.The cam support pin was broken and needed to be replaced along with the worn shock cushion, and the cam rod and set screw had rust.The probable root cause is routine wear and mishandling of the unit.Customer is recommended to follow the decontamination instructions carefully to avoid rust.No corrective action has been initiated for the same or similar issue.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: BASE UNITS AND ADAPTERS
• 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: 22555449
• Report Number: 3004608878-2025-00150
• Device Sequence Number: 9700164
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown