MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD ULTRA BASE UNIT A2101

Catalog Number	A2101
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield ultra base unit (a2101) 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 shows that the complaint is confirmed from the evaluation.The shock cushion has moved forward in the handle and is impeding the 6in transitional from going into the handle.The 6in transitional has worn threads, the buttonhead screw is missing from the left bracket, the isolator pins are broken in both brackets, the shock cushion and 1/4in pin are worn, and the adjustment wrench has worn threads.Since a patient injury was involved, the unit was sent to quality engineering (qe) for further investigation.Qe confirmed that the returned unit was missing the button head screw from the left bracket, so the bracket could not be secured, and the shock cushion was impeding the transitional.To resolve the issue, the adjustment screw, finishing cap, adjustment wrench, 1/4 pin, buttonhead screw, isolator pins, 6in transitional, shock cushion, labels and roll pin will be replaced by the completion of service.Root cause - the complaint is confirmed via inspection of the unit due to missing parts which allow it to move while locked into position.The probable root cause is rough or improper handling of the unit.Additionally, improper or suboptimal placement of the mayfield system can contribute to movement of slippage of the patient.No further corrective action beyond the aforementioned repairs 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.
Event or Problem Description
This is 1 of 3 reports linked to mfg report numbers 3004608878-2026-00017 and 3004608878-2026-00019: a facility reported that the patient was in the prone position for a craniotomy procedure and slipped from the mayfield ultra base unit (a2101).This resulted in an inch and a half deep laceration to the patient's left scalp which required suturing.Additional information has been requested.

• Brand Name: MAYFIELD ULTRA BASE UNIT A2101
• 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: 24405450
• Report Number: 3004608878-2026-00018
• Device Sequence Number: 15509706
• Product Code: FWZ
• UDI-Device Identifier: 10381780267997
• UDI-Public: 10381780267997
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: A2101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2016
• 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 SKULL CLAMP (A1059); MAYFIELD SWIVEL ADAPTOR (A1018)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown