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

Catalog Number	A3059
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during patient preparation under anesthesia, a defect was identified in the mayfield composite series clamp (a1059) which affected the locking mechanism on the side pins.The issue was detected after the device had already been applied to the patient.Due to the malfunction, the clamp had to be removed and replaced with another device, resulting in a delay of approximately 10 minutes.Although no serious injury occurred, the patient sustained unnecessary minor wounds caused by the pins during the event.
Additional Manufacturer Narrative
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 - inspection of the skull clamp reveals rotational play within its pivot locking assembly, and the locking mechanism is loose.Consequently, proper fixation of the patient's skull cannot be guaranteed.To resolve the issues, the internal components of the skull clamp were replaced to calibrate the device in accordance with the manufacturer's specifications and to clean the skull clamp's swivel locking assembly.Upon completion of the reassembly¿including calibration¿the skull clamp underwent a successful functional test and meets manufacturer specifications.Root cause - the complaint is confirmed via inspection of the unit since the unit needed replacement of worn parts.The probable root cause is routine use and wear.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.

• 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: 25185774
• Report Number: 3004608878-2026-00059
• Device Sequence Number: 10755708
• 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
• Report Date (Section B): 05/15/2026

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
• Date Returned to Manufacturer: 04/07/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2019
• 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
• Patient Sex: Unknown