MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Catalog Number	A2114
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that mayfield infinity xr2 skull clamp (a2114) was used in a posterior cervical fusion procedure and the pin slipped causing an abrasion to the patient's head.The lock did not stay engaged for the procedure.No surgical delay has been reported.
Additional Manufacturer Narrative
The mayfield infinity xr2 skull clamp (a2114) was returned for evaluation: device history record (dhr) - the dhr was reviewed shows no abnormalities related to the reported failure.Failure analysis - the investigation shows that the unit has a loose index knob caused by the set screw being loose, the pawls are showing signs of wear and will need to be replaced, and the adult rocker arm and 80lb torque knob have a sticky residue that will require disassembly and cleaning.Since a patient injury was involved, the unit was sent to quality engineering (qe) for further investigation.Qe confirmed the findings of the service team and noted that the returned unit had a loose index knob and signs of wear.No additional device deficiencies were noted.To resolve the issue, all worn components will be replaced with new parts, and general maintenance and cleaning will be performed.Root cause - the complaint is confirmed via inspection of the unit.The index knob is loose, and it is recommended that the unit receive a preventive maintenance (pm) service.The probable root cause is routine use and wear of the unit.No further corrective action 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 SKULL CLAMP
• 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: 23544288
• Report Number: 3004608878-2025-00214
• Device Sequence Number: 9609472
• Product Code: HBL
• UDI-Device Identifier: 10381780253761
• UDI-Public: 10381780253761
• Combination Product (Y/N): N
• PMA/510(K) Number: K130389
• 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): 11/13/2025

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: A2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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