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

Catalog Number	A2101
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
This is 1 of 3 reports linked to mfg report numbers: 3004608878-2026-00011, 3004608878-2026-00012.An authorized distributor reported that the mayfield ultra base unit (a2101) gave way and did not fix during surgery.The incident caused an increase in surgical time of more than 30 minutes, due to the need to manage the situation.There was no death, but rather lacerations to the scalp, constituting an injury associated with the event.The event occurred in (b)(6) hospital.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The mayfield ultra base unit (a2101) 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 inspection of the base unit shows that the left bracket is fixed too tight onto the connection tube.The dowel pin which fixates the bracket is deformed, and the left bracket must be opened by removing the finishing cap which is considered misuse of the device.The dowel pin needs to be replaced along with the button head screw to restore the function of the moveable bracket, and the end cap needs to be replaced, drilled and pinned to the connecting tube.The adjustment wrench is rusty and the thread is broken; therefore, the wrench needs to be replaced.The handle assembly's shock cushion has migrated out of its position in the casting and blocks the gold handle from closing properly; the handle assembly's shock cushion and the cam link support pin were removed and must be replaced.After completing the reassembly, and the adjustment of the base handle, the unit will be function tested to meet manufacturer specification.Root cause - the complaint is confirmed via inspection of the unit.The root cause is misuse of the unit causing wear and tear.No further corrective action beyond the 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.

• 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: 24329068
• Report Number: 3004608878-2026-00010
• Device Sequence Number: 9476109
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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: A2101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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 SKULL CLAMP (A1059).; MAYFIELD SWIVEL ADAPTOR (A1018).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown