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	01/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 3 reports linked to mfg report numbers 3004608878-2026-00017 and 3004608878-2026-00018: a facility reported that the patient was in the prone position for a craniotomy procedure and slipped from the mayfield modified skull clamp (a1059).This resulted in an inch and a half deep laceration to the patient's left scalp which required suturing.Additional information has been requested.
Additional Manufacturer Narrative
The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed shows no abnormalities related to the reported failure.Failure analysis - inspection of the returned unit shows that it is past the 10-year service life and has not been serviced since 2018.Therefore, the unit will be returned to the customer unrepaired.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 with the observation that the unit is heavily worn and has movement present in the lock.Root cause - the complaint is confirmed via inspection of the unit.However, the unit was past the 10 year mayfield service life and will be returned unrepaired.The probable root cause is routine use/wear of the unit and lack of preventive maintenance.Additionally, improper or suboptimal placement of the mayfield system can contribute to movement of slippage of the patient.No 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 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: 24405304
• Report Number: 3004608878-2026-00019
• Device Sequence Number: 8168393
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• Combination Product (Y/N): N
• PMA/510(K) Number: PRE-AMEND
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MAYFIELD SWIVEL ADAPTOR (A1018); MAYFIELD ULTRA BASE UNIT (A2101)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown