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	Laceration(s) (1946)
Date of Event	02/16/2026
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 during a "revision suboccipital craniectomy, c1-c2 laminectomies decompression" procedure, the patient slipped while pinned in the mayfield modified skull clamp (a1059).This resulted in a 3-4 inch laceration on the patient's scalp necessitating sutures for repair.Patient status is reported as "healing".There was no surgical delay.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.(b)(6) modified skull clamp (b)(6) was not returned for evaluation, and the device history record (dhr) cannot be identified as the provided serial number does not appear to be a valid (b)(6) serial number.However, based on included photos from the customer, and an examination of the device's history record, the device likely failed to secure the patient as a result of excessive wear due to age.The device has long surpassed integra's 10-year lifespan, as it was manufactured in 2009.The photos sent by the customer show excessive wear to the unit, along with visible residue buildup and scratches.The item's sku identifying marks are also flaked off but are still legible.The unit is etched with (b)(4), stamped with a1059 and lot code 091.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: 24597052
• Report Number: 3004608878-2026-00033
• Device Sequence Number: 9560976
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• 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
• Device Lot Number: 091
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 281 LB
• Patient Race: Black Or African American