MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number	A1114
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield infinity skull clamp (b)(6) was 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 unit showed that the lock had rotational and lateral movement and a residue buildup present.The lock is sticking and not fully engaging into the locked position.To resolve the issues, it is recommended that the unit receive a pm service.As a result, new components were added to replace worn internal parts along with general maintenance and cleaning performed.Root cause - the complaint is confirmed via inspection of the unit.The unit required preventive maintenance including cleaning and replacement of worn parts.The probable root cause is routine use and wear of the unit.Additionally, improper or suboptimal placement of the skull clamp can contribute to movement or slippage of the patient.No further investigation 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
This is 1 of 2 reports linked to mfg report number 3004608878-2025-00088: a facility reported that the mayfield infinity skull clamp (b)(6) was positioned in locking for "posterior cervical fusion" procedure when it released causing injury to the patient.Bleeding was observed from the laceration and the surgeon placed staples on the laceration.The mayfield pin was removed from the patient and replaced with another mayfield pin headrest.There was about 20-30 minutes of surgical delay as a result of product problem.

• Brand Name: MAYFIELD INFINITY SKULL CLAMP
• Common Device Name: SKULL CLAMPS AND HEADREST SYSTEMS
• 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: 21945010
• Report Number: 3004608878-2025-00090
• Device Sequence Number: 8802525
• Product Code: HBL
• UDI-Device Identifier: 10381780253549
• UDI-Public: 10381780253549
• Combination Product (Y/N): N
• PMA/510(K) Number: K051440
• 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
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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: (B)(6) MAYFIELD SKULL CLAMP.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown