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

Catalog Number	A1059
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the reported complaint is confirmed from the evaluation.The skull clamp has both rotational and lateral movement and a residue buildup is present.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.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 and noted that the unit was in worn condition and had significant movement present in the swivel lock.To resolve the issues, the roundhead screw, adjustment screw, label, screw, nut, washers, o-ring, ball bearings, wave springs and helicoils will be replaced.Root cause - the complaint is confirmed via inspection of the unit.The probable root cause is routine use and wear and improper maintenance resulting in rotational and lateral movement present in the lock with a residue buildup; requiring replacement of worn internal parts and cleaning.Additionally, the unit is over 6 years old and does not have a service history.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.
Event or Problem Description
A facility reported that during a posterior cervical fusion procedure, the locking mechanism of the mayfield modified skull clamp (a1059) did not engage which caused a scalp laceration to the patient requiring stiches to close the laceration.There was no surgical delay.The patient was discharged home on (b)(6) 2026.

• 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: 25060758
• Report Number: 3004608878-2026-00048
• Device Sequence Number: 18480111
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

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: 04/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2019
• 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: 67 YR
• Patient Sex: Female
• Patient Race: White