MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD

Catalog Number	A3101
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield composite series base unit, standard (a3101) was returned for evaluation: device history record (dhr) review- the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation showed that the complaint is confirmed from the evaluation.The handle tested low when put under pressure, the draw bar and viton ball are worn in the swivel adapter, and the left bracket has difficulty transitioning on the bar.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 and noted that the returned unit was in worn condition and the left bracket was stuck in place and difficult to move.No additional device deficiencies were noted.To resolve the issue, the draw bar, viton ball, and roll pin will be replaced.Root cause - the complaint is confirmed via inspection of the unit.The unit is four years old and has no service history.The handle tested low when put under pressure and the swivel adapter had worn parts.The left bracket also was difficult to move on the connecting tube.The probable root cause is routine use and wear and lack of maintenance.Based on the evaluation of the event, no further investigation 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 a patient suffered harm during shift in positioning, and that the mayfield composite series base unit, standard (a3101) needs to be tightened.The patient underwent "anterior dens screw and c3-c6 posterior spinal fusion procedure", and when the mayfield malfunctioned, it became misaligned with the patient's face which led to pressure points on the patient's eyeball.No surgical delay or medical intervention was reported.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h11.Adiditional information received: please provide details of the injury to the patient.--> the primary nurse did not provide details regarding the injury.
Event or Problem Description
N/a.

• Brand Name: MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD
• Common Device Name: COMPOSITE SERIES
• 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: 22554753
• Report Number: 3004608878-2025-00142
• Device Sequence Number: 9647525
• Product Code: FWZ
• UDI-Device Identifier: 10381780268161
• UDI-Public: 10381780268161
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: A3101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White