MAUDE Adverse Event Report: INTEGRA - PRINCETON DURAGEN PLUS DURAL REGENERATION MATRIX 4X5 1 PA; N/A

Catalog Number	DP1045
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
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 duragen plus dural regeneration matrix (dp1045) was implanted in a patient diagnosed with meningioma brain tumor.At the time of passing the sutures into the patch, it began to tear and even came loose from the traction points.Intraoperatively, the patient did not have any damage/injury from the event that occurred, and it is hoped that it will not cause a fistula later.The patient was reported to be in satisfactory recovery.
Additional Manufacturer Narrative
Duragen plus dural regeneration matrix (dp1045) was not returned for evaluation; therefore, an evaluation of the device could not be performed.However, investigation of retained samples was performed as follows: device history record (dhr) review - the dhr was reviewed, and no anomalies were found in any of the processes which could have contributed and/or be related with the reported condition being investigated.Failure analysis - eight (8) retain sample units were visually inspected: the outer box was in good condition, and the tray package and sealing area were in good condition.No defects were identified on any of the sponges, and all eight units had normal appearance.Medical assessment - a medical assessment was performed to evaluate the possible relation between the reported event and product use, and it concluded the following: ¿the device not causal to event.Per the instructions for use (ifu), duragen plus matrix is an onlay graft and does not require sutures; however, tensionless, atraumatic stay sutures may be use if desired.Suturable duragen dural regeneration matrix may have been the preferred implant as it is an absorbable implant for repair of dural defects.Suturable duragen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component.Suturable duragen is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.Suturable duragen may be applied using either onlay or suturing technique depending on clinical need and surgeon preference.¿ root cause - based on the available information, the satisfactory retain sample results, and the medical assessment performed, there is no information that confirms a device related malfunction.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: DURAGEN PLUS DURAL REGENERATION MATRIX 4X5 1 PA
• 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: 18897384
• Report Number: 1121308-2024-00009
• Device Sequence Number: 14985122
• Product Code: GXQ
• UDI-Device Identifier: 10381780023470
• UDI-Public: 10381780023470
• Combination Product (Y/N): N
• PMA/510(K) Number: P032693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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: 04/30/2026
• Device Catalogue Number: DP1045
• Device Lot Number: 7243067
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/26/2024
• Date Device Manufactured: 05/25/2023
• 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