MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP

Catalog Number	A3059
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
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
A facility reported that patient was in prone position in the mayfield composite series skull clamp (a3059) for a posterior cervical fusion procedure, and the patient's head slipped in the pins as the mayfield was not locking properly.There was no injury to the patient and a replacement mayfield was brought into the room.No surgical delay has been reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4 (udi), d9, g3, g6, h2, h3, h4, h11.Corrected field: d4 (serial#).The mayfield composite series skull clamp (a3059) 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 of the returned unit shows there is up and down movement in the lock, the index knob is cracked and not allowing the clamp to lock completely, and the rocker arm is sticking.Additionally, the unit has no recorded maintenance since it was purchased in 2021; therefore, it is recommended that it receive a preventive maintenance (pm) service at this time.To resolve the issues, the index knob, disk ratchet, retaining ring, screw, nut, washer and wave spring will be replaced along with general maintenance and cleaning.Root cause - the complaint is confirmed via inspection of the unit.The unit has no recorded maintenance since it was purchased in 2021and needs a pm service at this time.The probable root cause is rough handling of the unit.Additionally, improper or suboptimal placement of the skull clamp can contribute to 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.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• 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: 24333514
• Report Number: 3004608878-2026-00016
• Device Sequence Number: 4914309
• Product Code: HBL
• UDI-Device Identifier: 10381780253792
• UDI-Public: 10381780253792
• Combination Product (Y/N): N
• PMA/510(K) Number: K142238
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A3059
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• 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
• Patient Sex: Unknown