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

Catalog Number	A2101
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
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 inspection of the base unit showed it has a scratched and worn-off connection tube.The unit¿s brackets were disassembled, and the handle has been removed.The connection tube must be replaced with the finishing cap and a pair of roll pins to reassemble the unit.The left moveable bracket will be overhauled in the process.The end cap needs to be drilled and pinned to the connecting tube.The transitional member is not an integra-product and will be sent back to the customer.One transitional member must be added to the unit.The adjustment wrench is missing and must be added to the unit.The handle assembly's shock cushion and the cam link support pin were removed and must be replaced.Root cause - the complaint is confirmed via inspection of the unit.The unit had a scratched and worn connecting tube.The brackets were disassembled, and the handle was removed.The transitional member received was not an integra product.The handle assembly shock cushion and cam link support pin were removed.Probable root cause is improper handling and disassembly of the device.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
This is 1 of 3 reports linked to mfg report numbers 3004608878-2025-00080 and 3004608878-2025-00081: a facility reported that once fixed, the mayfield ultra base unit (a2101) was not stable.The problem was found on the patient under anesthesia, before the surgery.Since the patient could not give up this surgery, we minimized the movement of the headboard as much as possible, taking into account its imperfect stability for the entire duration of the surgery.There was no increased surgery time or patient injury.

• Brand Name: MAYFIELD ULTRA BASE UNIT
• 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: 21901683
• Report Number: 3004608878-2025-00079
• Device Sequence Number: 4059426
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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: A2101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2019
• 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; A1108 MAYFIELD TRIAD SKULL CLAMP
• Patient Sex: Unknown