MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR DURAGEN PLUS - ADHESION BARRIER MATRIX 7.5 CM X; N/A

Catalog Number	DP1033I
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that a patient who underwent surgery in (b)(6) 2024 came in for a revision craniotomy due to cerebrospinal fluid (csf) leakage.During the revision case, it was found that the duragen plus - adhesion barrier matrix (dp1033i) had disintegrated, and a small portion was found attached to the base of skull.The cerebellum was exposed which caused a major csf leak.The surgeon used "durs3391itl ¿ suturable duragen" for the revision surgery.
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
Duragen plus - adhesion barrier matrix (dp1033i) was not returned; therefore, an evaluation of the device could not be performed.However, visual inspection of the retained samples was performed as follows: 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.Failure analysis - one (1) unit was visually inspected.The dispenser boxes and contents were in good condition, the tray sealing area was complete, and no defects were observed on the sponges.Medical assessment - since some details of the case were provided, a medical assessment was performed to evaluate the possible relation between the reported event and product use.The assessment concludes the following: ¿there is insufficient information to conclude whether or not the adverse event reported was due to the duragen plus.Information regarding to the patient¿s relevant medical history, details surrounding the intra-operative procedure, surgical technique, and any concomitant devices (i.E.Surgical sealant) used were not provided.¿ root cause - based on the available information, the satisfactory retain sample results, and the conclusion of the medical assessment, there is no information that confirms a device related malfunction.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 - ADHESION BARRIER MATRIX 7.5 CM X
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20363834
• Report Number: 1121308-2024-00036
• Device Sequence Number: 6860072
• Product Code: GXQ
• UDI-Device Identifier: 10381780023463
• UDI-Public: 10381780023463
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: DP1033I
• Device Lot Number: 7365572
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2024
• 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: Required Intervention; Other
• Patient Sex: Unknown