MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD SWIVEL ADAPTOR A1018

Catalog Number	A1018
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 3 of 3 reports linked to mfg report numbers 3004608878-2026-00007 and 3004608878-2026-00030: a facility reported that the mayfield swivel adaptor (a1018) came loose during surgery, resulting in a single scratch to the patient's hairline/forehead, and a bandage was applied to the forehead.Another device was used to complete the surgery.The surgery time was not significantly increased.
Additional Manufacturer Narrative
The mayfield swivel adaptor (a1018) 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 swivel adapter a1018 with serial number (b)(6) shows no defects.The starburst teeth is in good working order and the torque screws are in good condition.The unit can be properly fixed into the submitted base unit and skull clamp and has no movement after fixation.The unit has been subjected to a successful functional check and it meets manufacturer specifications.Root cause - the complaint is not confirmed via inspection since the swivel adaptor shows no defects and is in good working order.The probable root cause is improper or suboptimal placement of the mayfield system or defect with the base unit or skull clamp.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.

• Brand Name: MAYFIELD SWIVEL ADAPTOR A1018
• 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: 24597053
• Report Number: 3004608878-2026-00031
• Device Sequence Number: 21222695
• Product Code: FWZ
• UDI-Device Identifier: 10381780267515
• UDI-Public: 10381780267515
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MAYFIELD MODIFIED SKULL CLAMP (A1059).; MAYFIELD ULTRA BASE UNIT (A2101).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown