MAUDE Adverse Event Report: INTEGRA - PRINCETON DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 1 PAC; N/A

Catalog Number	DP1013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is for the 1st infection case and is linked to mfg report numbers 1121308-2025-00033 and 1121308-2025-00034: a facility reported that duragen plus dural regeneration matrix 1x3 1 pac (b)(6)) was used during spinal surgery, and dural leaks were observed.Additionally, there were 3 infection cases during july/august.Additional information has been requested.
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.
Additional Manufacturer Narrative
Updated field: d4, d9, g3, g6, h2, h3, h6, h11.Duragen plus dural regeneration matrix (dp1013) was not returned and lot number information has not been provided; therefore, the device history record (dhr) could not be reviewed.Failure analysis is not possible since the unit involved in the complaint could not be returned for evaluation.No photos showing the reported condition have been provided; therefore, the complaint is considered unconfirmed.Notwithstanding the above, a medical assessment was performed to evaluate the possible relation between the reported event and product use.The assessment concludes the following: ¿based on the complaint information received and reviewed to date, there is insufficient information to conclude that the reported cerebrospinal fluid (csf) leaks and infections were due to the duragen plus.Device trending analysis indicates no trend, and the complaint report lacks any detailed patient and event information, including relevant patient medical history, laboratory test with results (including culture, type of organism), details surrounding the intra-operative procedures, surgical technique, concomitant devices (i.E.Surgical sealants) used and post-operative cate.There was no mention of any sterility or packaging breach with the duragen plus at the time of the report.Lot number(s) of the implanted duragen(s) was also not provided, and additional information has been requested by the complaints department, but to date, no further information has been received from the customer.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 1 PAC
• Common Device Name: N/A
• 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: 23204069
• Report Number: 1121308-2025-00032
• Device Sequence Number: 10080708
• Product Code: GXQ
• UDI-Device Identifier: 10381780023449
• UDI-Public: 10381780023449
• Combination Product (Y/N): N
• PMA/510(K) Number: K032693
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: DP1013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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