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

Catalog Number	A3059
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the swivel arm locking mechanism on the mayfield composite series skull clamp (a3059) was defective during clamping / fixing and during the surgery.There was no patient injury or increased surgery time.
Additional Manufacturer Narrative
The mayfield composite series skull clamp (a3059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the customer's statement is confirmed as valid after evaluating the device.Inspection of the skull clamp shows that the locking mechanism is loose and does not close properly.When opened, it was found that the index knob is broken, and as a result, the thread does not engage correctly and therefore does not provide a stable hold.The knob, along with the corresponding ratchet, must be replaced, and the locking mechanism must be readjusted according to the manufacturer's specifications.Additionally, the small parts of the toggle lever (washers, groove, and screw) must be replaced due to wear.To resolve the issues, the black index button was replaced with a ratchet mechanism, the worn internal parts were replaced, the locking mechanism was adjusted, and the small parts of the rocker arms were replaced.Subsequently, the device underwent a successful functional test and meets manufacturer specifications.Root cause - the complaint is confirmed via inspection of the unit.The locking mechanism was loose and did not close properly.The index knob was broken, preventing the knob/lock from holding properly, and the unit needed replacement of damaged and worn parts.The probable root cause is routine wear and rough handling of the unit.No further corrective action beyond the necessary repair 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
N/a.

• 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: 23845503
• Report Number: 3004608878-2025-00241
• Device Sequence Number: 9572124
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 11/26/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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