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

Catalog Number	A1059
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
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 mayfield modified skull clamp (a1059) was used for a chiari surgery and at some point during the procedure, the patient's head slipped out of the clamp while in prone position.This resulted in a gash from the skull pin, and there was blood on the floor from the slip.The doctor fixed the gash before proceeding, re-secured the patient and continued the surgery.The case was completed as normal following the event.Surgical delay is unknown at this time.Additional information has been requested.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11 (b)(6) modified skull clamp (a1059) was not returned.However, based on the complaint background, the customer is unsure if the slip was a result of the placement on the patient or the device itself.After the patient slipped, the surgeon was able to re-secure the patient and continue the surgery.The device was also checked post-op, and found to be functioning as needed, but the c clamp was loose.The procedure was able to be concluded with no further injury to the patient.The device's history record was examined, and no manufacturing defects were noted.The device was manufactured in 2014 - surpassing integra's recommended 7-year lifespan.If the device is returned or additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• 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: 24650840
• Report Number: 3004608878-2026-00034
• Device Sequence Number: 18602503
• Product Code: HBL
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2014
• 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 Sex: Unknown