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	Laceration(s) (1946)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The facility reported that during "stereotactic placement of laser probes; laser ablation of right amygdala and hippocampus; laser ablation of periventricular heterotopia procedure", the mayfield composite series skull clamp (a3059) disengaged causing a laceration to the patient.Per surgeon's operative note, the mayfield released prior to initiating registration resulting in a 3cm laceration that was prepped and stapled to repair.There was a 15 minute surgical delay.The patient is now discharged.
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 - investigation of the returned unit shows that the unit passes all specific functional testing, and a repeat of slippage or disengagement could not be duplicated.Further, since a patient injury was involved, the unit was sent to quality engineering (qe) for further investigation.Qe confirmed the initial findings of the service team and no functional issues were observed with the unit.It was noted that the ratchet extension and clamp base were mis-matched; the ratchet extension was marked (b)(6), and the clamp base was marked (b)(6).Root cause - the complaint is not confirmed for slippage since the unit passed all specific functional testing.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.

• 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: 25185778
• Report Number: 3004608878-2026-00058
• Device Sequence Number: 10755712
• 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
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White