MAUDE Adverse Event Report: Integra LifeSciences Corporation OH/USA MAYFIELD INFINITY SKULL CLAMP

Catalog Number	A1114
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11 the mayfield infinity skull clamp (a1114) 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 skull clamp shows the skull clamp has rotational movement in its swivel lock assembly and a residue buildup is present.Which does not guarantee proper fixation of the patient's skull.For the adjustment of the lock assembly, new components need to be added to replace worn internal parts.To resolve the issues, the skull clamps internal parts were replaced to adjust the unit according to the manufacturer specifications and to clean the skull clamp's swivel lock assembly.After completing the reassembly, including the adjustment, the skull clamp was subjected to a successful function test and was confirmed to meet all manufacturer specifications.Root cause - the complaint is confirmed via inspection of the unit.The clamp had rotational movement in its swivel lock assembly and residue buildup, requiring cleaning and replacement of worn parts.The probable root cause is routine use and wear.Additionally, improper or suboptimal placement of the skull clamp can continue to movement or slippage of the patient.No further investigation 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
N/a.

• Brand Name: MAYFIELD INFINITY 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 ; +1(609)936-2319
• MDR Report Key: 50025999
• Report Number: 3004608878-2026-00082
• Device Sequence Number: 18543551
• Product Code: HBL
• UDI-Device Identifier: 10381780253549
• UDI-Public: 10381780253549
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: A1114
• Device Lot Number: 121745/151
• Date Returned to Manufacturer: 07/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2015
• 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
• Patient Sex: Unknown