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	07/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
This is 4 of 4 reports linked to mfg report numbers: 3003418325-2022-00019.1121308-2022-00097.3003418325-2022-00020.A facility reported that on (b)(6) 2022, duragen suturable + duraseal was used in an unspecified surgery and on (b)(6) 2022, the surgeon requested for re-intervention as patient presented with cerebrospinal fluid (csf) fistula.They considered removing and cleaning to place a new duragen suturable + duraseal.The second surgery was scheduled on (b)(6) 2022 where duragen suturable + duraseal was used again.On (b)(6) 2022, the surgeon reported that the patient presented with csf fistula again and said surgeon requested re-intervention, considering not using integra products.There was an unspecified delay in surgery.
Additional Manufacturer Narrative
Correction: d4 (lot number was incorrectly reported as serial # in initial mdr).Duragen suturable dural regeneration template 3 (durs3391) was not returned for evaluation; as per customer, it was discarded in surgery.However, investigation of retained samples was performed as follows: device history record (dhr) review - lot number information has been provided; therefore, the dhr was reviewed and found no anomalies.Failure analysis - eight (8) retained sample units were visually inspected and no anomaly was observed in product or packaging appearance.Root cause - a root cause determination is not possible at this time, and a scientific affairs assessment is not possible due to the limited information provided in the complaint.Additional information was requested to further evaluate the reported event, but no response has been received.In addition, the retained samples evaluation was satisfactory; no anomaly was observed in product or packaging appearance.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.

• 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: 15474515
• Report Number: 1121308-2022-00098
• Device Sequence Number: 19562871
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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: 03/31/2024
• Device Model Number: DURS3391
• Device Catalogue Number: DURS3391
• Device Lot Number: 6234486
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/07/2022
• Date Device Manufactured: 03/17/2022
• 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: Female