MAUDE Adverse Event Report: INTEGRA - PRINCETON DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 5 PAC; N/A

Catalog Number	DP5013
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
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
This report is 2 of 3 and linked to mfg report numbers 1121308-2025-00011 and 1121308-2025-00014: a facility reported that 3 dura leaks (csf leakage) with the same lot number of the duragen plus dural regeneration matrix (dp5013) occurred post surgery.No product has been removed from patients, but product with the same lot number has been removed from circulation.Additional information is being requested.
Additional Manufacturer Narrative
Updated fields: additional information has been received indicating the following: incident occurring on (b)(6) 2025 - 1.What revision/medical intervention was performed after csf leak occurred? answer: hospitalization for observation.2.How much csf leaked during the incident (if an exact amount cannot be provided, please provide an approximate amount: small amount, moderate, etc.)? answer: moderate.4.Was the patient moved, or being moved at the time of the incident? answer: unknown.5.Please provide patient outcome answer: expected outcome for which surgery was performed.6.What type of procedure was duragen used for? answer: suboccipital crani for microvascular decompression.Investigation findings: duragen plus dural regeneration matrix (dp5013) was not returned for evaluation for the units involved in the six (6) cases reported.According to the complaint information no product will be returned and the product with the same lot number was removed from circulation.Also, no photo showing the reported condition and/or product was provided; thus, the reported lot number cannot be confirmed either.However, investigation of retained samples was performed.Device history record (dhr) review - the dhr was reviewed, and no anomalies were found during the manufacturing and packaging process that could be related to the reported condition.Retained sample failure analysis - five (5) units were visually inspected.The dispenser box and contents were in good condition, tray sealing area was complete in each unit, no defects were observed on any of the five (5) sponges, and no foreign material presence was observed.Retained sample medical assessment - a medical assessment was performed to evaluate the possible relation between the reported event and product use and concludes as follows: ¿there is insufficient information to conclude whether the reported adverse event of cerebrospinal fluid (csf) leak post-surgery was due to the duragen plus.The reported complaints lack detailed patient and event information, including the timeframe of implant date to incident date, patient¿s relevant medical history, details surrounding the intra-operative procedure, surgical technique, and any concomitant devices (i.E.Surgical sealants) used.Further information has been requested by the complaints department but to date, no additional response has been received from the customer.¿ retained sample root cause - based on the available information, there is insufficient information to conclude whether the reported adverse events of cerebrospinal fluid (csf) leak post-surgery were due to the duragen plus.All reports are from a common source which may suggest that the situation may be technique and/or user related.For now, integra will continue to monitor for possible recurrence for trending purposes and to evaluate if any actions are required in the future.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: additional information was also received for this case as follows: the timeframe of implant date to incident date (b)(6)2025.Patient¿s relevant medical history- >> breast cancer.Details surrounding the intra-operative procedure the wound was copiously irrigated with lr.We closed the dura using 4-0 nurolon's in interrupted fashion.This was covered with a small duragen.The bone flap was now plated with a large bur hole cover and a dog bone.This is reaffixed to the skull using titanium screws.Tisseel was now injected underneath the bone flap.The scalp was now irrigated and then closed in layered fashion.Surgical technique (sterile, documented surgical class as clean procedure) any concomitant devices (i.E.Surgical sealants) used.(vistaseal).
Event or Problem Description
N/a.

• Brand Name: DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 5 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: 21851690
• Report Number: 1121308-2025-00013
• Device Sequence Number: 18133400
• Product Code: GXQ
• UDI-Device Identifier: 10381780070924
• UDI-Public: 10381780070924
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2025

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: DP5013
• Device Lot Number: 7377759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 06/12/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 06/11/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 61 KG