MAUDE Adverse Event Report: INTEGRA - PRINCETON DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 3; N/A

Model Number	DURS3391
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	02/19/2023
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 duragen suturable dural regeneration template 3 (durs3391) was used during a ventricular shunt of the patient and after 24 postoperative hours, the patient presented a cerebrospinal fluid (csf) fistula again requiring a reoperation or fistula closure.There was a delay of few minutes due to product problem.Patient was reported as stable.
Additional Manufacturer Narrative
The duragen suturable dural regeneration template 3 (durs3391) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Device history record (dhr) review - lot number information has been provided; therefore, the dhr was reviewed and found no anomalies.Failure analysis - eight (8) retain sample units were visually inspected.No defects in the sponge or tray packaging were observed.Root cause - based on the limited information provided, the two most likely causes for the reported condition, per scientific affairs, are: surgeon error ¿ insufficient overlap with existing dura and/or sutures not placed appropriately.Undetected underlying hydrocephalus related to the condition or as a result of the surgical procedure.Therefore, based on the information available the possible root cause for the reported event could be related to insufficient overlap with existing dura or undetected underlying hydrocephalus.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 SUTURABLE DURAL REGENERATION TEMPLATE 3
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16645739
• Report Number: 1121308-2023-00010
• Device Sequence Number: 12135282
• Product Code: GXQ
• UDI-Device Identifier: 10381780023517
• UDI-Public: 10381780023517
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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: 01/31/2024
• Device Model Number: DURS3391
• Device Catalogue Number: DURS3391
• Device Lot Number: 6056646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/14/2023
• Date Device Manufactured: 01/19/2022
• 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
• Patient Sex: Male