MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 1; N/A

Model Number	DURS1391
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	05/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Duragen suturable dural regeneration (durs1391) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed and found no anomalies.The root cause of the reported issue could not be determined.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
An adverse event was reported under (b)(6) clinical study ((b)(6)) with the following information: it was reported that a male patient in this study had a cerebrospinal fluid (csf) leak.A replacement of lumbar drain resolved the issue with no further problems.See additional details of the adverse event as follows: device information: cat#/product code# (durs1391).Surgery date: on (b)(6) 2021.Date of discharge: on (b)(6) 2021.Patient diagnosis: brain tumor.Surgical region: supratentorial.Surgical procedure: transphenoidal tumor removal.Adverse event: ae term: cerebrospinal fluid leak.Adverse event onset or start date: on (b)(6) 2021.Did the ae result in an initial or prolonged hospitalization: no.Did the ae require intervention to prevent permanent impairment or damage?: no.Details of intervention: replacement of lumbar drain.Outcome: resolved without sequelae (csf rhinorrhea resolved on (b)(6) 2021 after replacement of lumbar drain.No further issues).Adverse event resolution/end date: on (b)(6) 2021.

• Brand Name: DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 1
• 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
• MDR Report Key: 12643961
• Report Number: 1121308-2021-00046
• Device Sequence Number: 13763123
• Product Code: GXQ
• UDI-Device Identifier: 10381780023494
• UDI-Public: 10381780023494
• Combination Product (Y/N): N
• PMA/510(K) Number: K043427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2021

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 Expiration Date: 06/30/2022
• Device Model Number: DURS1391
• Device Catalogue Number: DURS1391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2021
• Initial Report FDA Received Date: 10/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 202