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

Catalog Number	A1059
Medical Device Problem Codes	Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) (1946); Unspecified Tissue Injury (4559)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that during shift in positioning in the mayfield modified skull clamp (a1059), the patient suffered harm.Additional information has been requested.
Additional Manufacturer Narrative
The mayfield modified skull clamp (a1059) is 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 both rotational and lateral movement and a residue buildup is present.The index knob and the lock will need new components added to replace worn internal parts, and the unit will need to be machined to have heli-coils added to large starburst threads.The unit does not have a service history since purchased in 2020, and it is recommended that preventive maintenance (pm) be performed.Further, since a patient injury was involved, the unit was sent to quality engineering (qe) for further investigation.Qe confirmed the findings of the service team with the observation that the unit was in worn condition and had movement present in the lock.To resolve the observed issues, the roundhead screw, adjustment screw, label, screw, nut, washers, o-ring, ball bearings, wave springs and helicoils will be replaced along with general maintenance and cleaning.Root cause - the complaint is not confirmed for any known failure with potential for injury, and it is unclear as to how the injury occurred.The clamp does have some difficulty locking due to heavy residue build up in the locking mechanism; however, when the clamp is properly positioned and put under pressure, it did not move.Additionally, the unit does not have a service history since purchased in 2020 and requires a pm service.The probable root cause of the reported complaint is 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 identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
Updated field: a1, a2, a3, a3a, a4, a5, a6, g3, g6, h2, h6, h11 additional information has been received as follows: 1.What type of procedure/surgery was the product used? >> c2-t2 posterior cervical decompression and fusion with biopsy of c5-6.2.Can you please provide more information about patient¿s injury (laceration, etc.)? >> approx 3" laceration on the left posterior temporal aspect of the scalp 3.Was there a delay in surgery due to product problem? if yes, how long? yes, 60 to 75 minute delay.4.Was medical/surgical intervention required? if yes, what revision/intervention was performed during the incident? >> shaved hair around the laceration, applied pressure for approximately 30 minutes, area cleaned with chloraprep, multi-layered sutured, and bacitracin ointment and island dressing was applied.
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: 24649971
• Report Number: 3004608878-2026-00036
• Device Sequence Number: 10208036
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 02/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• 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: 89 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White