MAUDE Adverse Event Report: INTEGRA - PRINCETON DURAGEN 3X3 1 PACK CE; DURAL REPAIR

Catalog Number	ID3301I
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Purulent Discharge (1812); Paralysis (1997)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that id3301i duragen 3x3 1 pack ce was implanted on an unknown date, and after a month, the patient showed symptoms of paralysis.Diagnostic imaging showed cyst formation in epidural after the formation of dura matter.Reoperation was performed, and pus-like matter was observed on the regenerated dura mater which was removed completely.Bacterial examination was performed but it was negative.After the reoperation, the symptoms were gone, and the patient is on follow-up.The bacterial examination is continuously performed.Additional information was received as follows: 1.What treatment and or medication was given¿ if medications were administered, please include medication names.Unknown 2.What is the health history of the patient? brain tumor 3.Patient outcome and or status.: follow-up.The symptoms resided.

• Brand Name: DURAGEN 3X3 1 PACK CE
• Common Device Name: DURAL REPAIR
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 24094988
• Report Number: 1121308-2026-00001
• Device Sequence Number: 14260921
• Product Code: GXQ
• Combination Product (Y/N): N
• PMA/510(K) Number: K982180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ID3301I
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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