MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD SWIVEL ADAPTOR; N/A

Catalog Number	A1018
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This is 4 of 4 reports linked to mfg report numbers: 3004608878-2025-00223 3004608878-2025-00224.3004608878-2025-00225.The mayfield modified swivel adaptor (a1018) was being used for a posterior cervical procedure, and the facility's surgeon reported that he thought he felt a slip when he drilled.The patient was unharmed, and there was no surgical delay.
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 investigation of the returned unit was unable to duplicate slippage.The teeth on the swivel adapter show some wear from routine use but still passes all specific functional testing.By the completion of service, the swivel sleeve, washers, retaining rings and label will be replaced and general maintenance and cleaning will be performed.Root cause - the complaint is not confirmed for slippage.The teeth on the swivel adapter does show some wear from routine use, but the unit still passed all specific functional testing.Additionally, improper or suboptimal placement of the mayfield system on the patient can contribute to movement or slippage.No further corrective action 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
• Common Device Name: N/A
• 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: 23662848
• Report Number: 3004608878-2025-00220
• Device Sequence Number: 9123925
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2019
• 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: A1059 MAYFIELD SKULL CLAMP; A1113 MAYFIELD NEUROGEN ADAPTOR; A2101 MAYFIELD ULTRA BASE UNIT
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG