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

Catalog Number	A1059
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the mayfield composite series skull clamp (a3059) was not tightening properly, and moved whilst in use.Additional information has been requested.
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
N/a.
Additional Manufacturer Narrative
Updated fields: b3, g3, g6, h2.Corrected field: h11 (was missing "additional information").Additional information received: 1.Date of incident: on (b)(6) 2025.2.What type of procedure was performed during the incident? cranial surgery.3.Was there a delay in surgery due to product problem? if yes, how long? delay unknown.Still waiting for more information from the customer.4.Was there any patient injury involved? no patient injury reported.Patient outcome is unknown.Still waiting for more information.5.How was the procedure completed? unknown.Still waiting for more information from the customer.
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 device shows that it passes all tests; was unable to duplicate slippage.The starburst and locking mechanism are intact and no slippage is observed.The internals of the locking mechanism were also inspected, and no repairs are required.This device will be returned in received condition.Root cause - the complaint is not confirmed, and the device passes all specific functional testing.The probable root cause of the reported complaint includes improper or suboptimal placement of the skull clamp on the patient.No further investigation 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 MODIFIED 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: 23796697
• Report Number: 3004608878-2025-00238
• Device Sequence Number: 12149206
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2026

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: A1059
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 01/15/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/14/2026; 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2021
• 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