MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 BASE UNIT

Catalog Number	A2079
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is 2 of 2 and linked to mfg report number 3004608878-2025-00168: a facility reported that the mayfield infinity xr2 base unit (a2079) was used in a craniotomy procedure, and while the patient was draped and microscope was in use, the surgeon felt a vibration.They checked the patient, and everything appeared to be fine.However, the patient moved, and they checked and saw that the base unit had moved and the patient's head fell out of the pins causing 2 lacerations of 1-2 inches to the back of the head.Two separate surgical staples were required.There was no delay in surgery.The procedure was completed, and the patient was discharged with no notable physical injury other than the 2 lacerations.
Additional Manufacturer Narrative
The mayfield infinity xr2 base unit (a2079) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned unit was unable to duplicate slippage/movement.The last service on the unit was in 2019, and the unit is over 10 years old and past it's service life.However, the unit passes all specific functional testing.Due to the 10-year device service life passed, the unit will be returned unrepaired to the customer after it is investigated by quality engineering (qe).Qe confirmed the initial findings of the service team that the unit was in worn condition, but no issues were observed.Root cause - the complaint is not confirmed, and the unit passes all specific functional testing.The device is over 10 years old and past it's service life with the last service occurring in 2019.The probable root cause of the reported complaint is improper or suboptimal placement of the mayfield system on the patient.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 INFINITY XR2 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: 22878762
• Report Number: 3004608878-2025-00169
• Device Sequence Number: 17586502
• Product Code: FWZ
• UDI-Device Identifier: 10381780267959
• UDI-Public: 10381780267959
• 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: Other
• Type of Report: Initial
• 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: A2079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Weight: 89 KG