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	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during a case, the patient's head slipped in the mayfield composite series skull clamp (a3059) while the screw was being placed.The surgeon verified that all parts were tightened and locked.There was no patient injury.Additional information received as follows: 1.Any other pertinent details of the incident? answer: in middle of the case, surgeon was placing a cervical screw, felt the patient shift to one direction and then back to original position when screw was going in.2.What type of procedure/surgery was performed during the incident? answer: cervical spine posterior fusion c/navigation: occipital - c6 fusion c/c3-c5 laminectomy 3.Was there a delay in surgery due to product problem? if yes, how long in minutes? answer: yes, approximately 7 minutes of delay time, due to a surgeon scrubbing out to assist team lead in double checking the equipment, making sure all points were secured.4.When placing the skull clamp, if you were to draw an imaginary line between the single pin and the rocker arm swivel point, did that imaginary line pass through an axial center of the skull? answer: yes 5.Did each pin engage the cranium in a perpendicular approach? answer: yes 6.How was the procedure completed? answer: normal closure, no issues.
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.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 - investigation of the returned unit was unable to duplicate slippage.When the clamp is properly positioned and put under pressure, it did not move.However, the unit has up and down movement in the lock, and the lock is ratcheting while unlocked.To resolve the issue, the disk ratchet, retaining ring, screw, nut, washer and wave spring will be replaced, and general maintenance and cleaning will be performed.Root cause - the complaint is not confirmed for slippage.When the clamp is properly positioned and put under pressure, it did not move.The unit does have movement in the lock, but this would not cause any movement once put under pressure.The probable root cause of the reported complaint is improper or suboptimal placement of the skull clamp on the patient.No further corrective action 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.
Event or Problem Description
N/a.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Common Device Name: COMPOSITE SERIES
• 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: 23325135
• Report Number: 3004608878-2025-00189
• Device Sequence Number: 18800945
• 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): 11/14/2025

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: 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: 09/22/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2019
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 107 KG