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 Codes	Laceration(s) (1946); Unspecified Tissue Injury (4559)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield infinity skull clamp (a1114) 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 shows that the clamp does have a slight rotational movement in the lock; however, this would not cause it to come unlocked when put under pressure.When the clamp was properly positioned and put under pressure, it does not move.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 minor signs of use and there was some debris/residue noted on the torque screw threads.No other issues were observed.To resolve the observed issues, all worn components were replaced, and general maintenance and cleaning were performed.Root cause - the complaint is not confirmed as the investigation was unable to duplicate slippage.The clamp does have a slight rotational movement in the lock, but when it is properly positioned and put under pressure, it would not move.The probable root cause of the reported complaint is improper or suboptimal placement of the skull clamp on the patient.No further 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.
Event or Problem Description
A facility reported that the mayfield infinity skull clamp (a1114) moved and loosened.The patient was pinned and flipped in typical manner and when tucking the patient in prone position, the head holder moved even when locked and was not holding the locking mechanism.They readjusted, unlocked, relocated and tried again and it rotated again this time and the entire mayfield loosened, then skived.Very little pressure was applied to the system either time, and the pins were firmly in the skull with 70lbs pressure noted before and after flipping.There was unknown patient injury.
Additional Manufacturer Narrative
Updated fields: a2, a3a, a4, a5, b3, g3, g6, h2, h6 (clinical and impact codes), h11.Additional information received: date of incident: november 12, 2025.What type of procedure/surgery was the device used for? c1-2 posterior instrumented fusion.What revision/medical intervention was performed during the incident? patient assessment and staple applied to the laceration.Faulty mayfield removed from circulation, and a different mayfield was obtained for the procedure.Was there a delay in surgery due to product problem? small delay associated with assessment and care of the laceration and obtaining a different mayfield for placement.Were there any patient adverse consequences because of the delay? no.How was the procedure completed? the procedure was completed with a different mayfield.Please provide patient outcome.The patient appeared to tolerate the procedure well, was extubated, and sent to pacu in stable condition for recovery.
Event or Problem Description
N/a.

• 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: 23733244
• Report Number: 3004608878-2025-00226
• Device Sequence Number: 21268061
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: A1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American