MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD NEUROGEN ADAPTOR; BASE UNITS AND ADAPTERS

Catalog Number	A1113
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
Additional Manufacturer Narrative
The mayfield neurogen adaptor (a1113) was returned for evaluation: device history record (dhr) review - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation was unable to duplicate slippage.However, the unit has bent long handle assemblies, and the short handle assemblies are showing some wear and will need the holes re-tapped on the base.To resolve the issue, the long handle assemblies, short handle assemblies and labels will be replaced to restore functionality.Root cause - the complaint is not confirmed for slippage.However, repairs are needed to replace the assemblies of the unit.The probable root cause is rough handling and routine wear.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.
Event or Problem Description
This is 2 of 4 reports linked to mfg report numbers: 3004608878-2025-00220 3004608878-2025-00223.3004608878-2025-00224.The mayfield neurogen adaptor (a1113) 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.

• Brand Name: MAYFIELD NEUROGEN ADAPTOR
• Common Device Name: BASE UNITS AND ADAPTERS
• 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: 23662621
• Report Number: 3004608878-2025-00225
• Device Sequence Number: 9082467
• Product Code: FWZ
• UDI-Device Identifier: 10381780267751
• UDI-Public: 10381780267751
• 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: 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: A1113
• 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: 09/20/2019
• 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: A1018 MAYFIELD SWIVEL ADAPTOR; A1059 MAYFIELD SKULL CLAMP; A2101 MAYFIELD ULTRA BASE UNIT
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Race: White