MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA OMNI-ACCESS STERILE FIELD POST, 3/4; OMNI-TRACT

Catalog Number	10707
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The omni-access sterile field post, 3/4 (10707) was returned for evaluation: the device history record (dhr) was not reviewed, as no lot/serial/manufacture date information was provided.The dhr may be reviewed, if necessary, if/when enough further information is provided or can be identified.Failure analysis: the returned omni-access sterile field post was in used condition.The clamp moves in a locked condition.Parts were replaced per the estimate and tested to the manufacturer's specifications.Root cause analysis: the reported complaint was confirmed.Based on the evaluation by integra service and repair, the root cause is most likely mishandling and/or wear from use without preventive maintenance.The date of sale was in 2015.
Event or Problem Description
A facility reported that during an abdominal aortic aneurysm procedure, the omni-access sterile field post (10707) wishbone frame did not attach or lock to the field post correctly during the surgery.The patient was prepped, and under anesthesia, and the malfunction resulted in a 30-minute surgical delay.There was no injury or death reported.

• Brand Name: OMNI-ACCESS STERILE FIELD POST, 3/4
• Common Device Name: OMNI-TRACT
• 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: 24397347
• Report Number: 3014334038-2026-00010
• Device Sequence Number: 15533393
• Product Code: GAD
• UDI-Device Identifier: 10381780271512
• UDI-Public: 10381780271512
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown