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	Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that the mayfield infinity skull clamp (a1114) moved and the patient slipped out of the pins resulting in an unspecified patient injury.No further information has been provided.
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 -evaluation of the returned unit was unable to duplicate slippage.However, the evaluation showed that there was slight rotational movement in the lock, and when the unit was disassembled, there was a residue build up in the lock.However, when the clamp is properly positioned and put under pressure, it does not move.Additionally, the unit was received with the triad rocker arm instead of the adult rocker arm assembly.To resolve the wear issues found, it is recommendation that the unit receive a pm with replacement of all worn components along with general cleaning and maintenance.Further, since patient injury was involved, the unit was sent to quality engineering (qe) for further investigation and the findings of the service & repair report were confirmed by qe with no additional device deficiencies observed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint, and slippage could not be duplicated.The clamp does have a little bit of movement without any pressure on it, but when the clamp is properly positioned and put under pressure, it does not move.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.

• 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: 21074577
• Report Number: 3004608878-2024-00170
• Device Sequence Number: 6899035
• 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
• Report Date (Section B): 01/03/2025

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: 11/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2019
• 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 Sex: Unknown