MAUDE Adverse Event Report: INTEGRA - PRINCETON DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 2; N/A

Catalog Number	DURS2291
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	05/16/2023
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 after being sutured, the duragen suturable dural regeneration template 2 (durs2291) had multiple pores allowing the passage of cerebrospinal fluid.There was no delay nor patient injury reported.Additional information received indicates the following: for what type of procedure was product used? external lumbar shunt which yarn was used? polypropylene l402mr22ap 75cm.Was the thread used absorbable or not? nonabsorbable.Which needle was used? needles 2cm 1/2 circle.Cylindrical cardiovascular.Was a dural sealant used? no was there permanent injury to the patient? no patient's current status: stable but remains hospitalized.A non-suturable duragen was used to replace the suturable duragen.Tisseel biological glue was also used as reinforcement.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Duragen suturable dural regeneration template 2 (durs2291) was not returned for evaluation.However, evaluation of retained samples was performed as follows: device history record (dhr) review: lot number information has been provided; therefore, the dhr was reviewed nd no anomalies were found during the manufacturing and packaging processes.Retain sample evaluation: eight (8) boxes were visually inspected: dispenser boxes and contents were in good condition, tray sealing area was complete, no defects were observed on the sponge product, and suture retention strength test performed to retain sample was satisfactory.Medical assessment: a medical assessment was performed to evaluate the possible relation between the reported event and product use.The assessment concluded the following: "the information contained within the complaint does not confirm an occurrence of device malfunction.Pores are microscopic but if there were holes in the matrix (not suture holes) the device should have been returned for investigation.Should cerebrospinal fluid (csf) exude from the matrix during valsalva, typically duraseal is used.This did not occur in the instance; however, when the non-suturable matrix was used, tisseel biological glue was also used as reinforcement." root cause: based on the available information and the medical assessment provided, there is no information that confirms an occurrence of device 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 SUTURABLE DURAL REGENERATION TEMPLATE 2
• 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: 18284136
• Report Number: 1121308-2023-00039
• Device Sequence Number: 6847041
• Product Code: GXQ
• UDI-Device Identifier: 10381780023500
• UDI-Public: 10381780023500
• 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): 01/19/2024

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 Expiration Date: 11/30/2023
• Device Catalogue Number: DURS2291
• Device Lot Number: 5902946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/19/2024
• Date Device Manufactured: 11/08/2021
• 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: Unknown