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

Catalog Number	DURS1391
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
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 upon implantation and as the surgeon was placing sutures, the duragen suturable regeneration (durs1391) graft kept tearing.The technician who was in the room also said a piece of the graft tore off the corner of the 1 x 3.The surgeon had used the product on other surgeries without any issues so there was a point of concern, hence the complaint.The incident led to a delay of at least half an hour due to multiple stitches not holding, but no patient injury was reported.
Additional Manufacturer Narrative
The duragen suturable dural regeneration template durs1391)) was not returned for evaluation; however, investigation of 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: ten (10) units were visually inspected.Dispenser boxes and contents were in good condition, tray sealing area was complete, no defects were observed on the sponges, and suture retention strength test performed to the retained sample was satisfactory.Medical assessment: a medical assessment was provided to evaluate the possible relation between the reported event and product use.The assessment concludes the following: "there is no information nor returned of a device remnant to confirm device related malfunction.In addition, no adverse patient consequences occurred from the procedure, i.E., leakage were reported.Finally there was no additional matrix utilized to complete the procedure indicating that the device was of sufficient strength to complete the procedure and release the patient." 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.
Event or Problem Description
N/a.

• Brand Name: DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 1
• 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: 18384308
• Report Number: 1121308-2023-00043
• Device Sequence Number: 19507913
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: DURS1391
• Device Lot Number: 7257544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/01/2024
• Date Device Manufactured: 07/26/2023
• 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