MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURAGEN PLUS DURAL REGENERATION MATRIX 2X2 1 PA; N/A

Catalog Number	DP1022
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that when introducing the dura graft transphenoidally, when passing through the nasal duct, the duragen plus dural regenation matrix 2x2 (dp1022) became a ball that was difficult to manipulate.The physician could not extend it in its entirety at the surgical site, so it was left in the form of a plug and filled with a tessel-type fibrin sealant to guarantee closure and avoid fistula in the post-operative period.There was no patient injury reported.
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Duragen plus dural regenation matrix 2x2 (dp1022) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Videos were provided by the customer; however, it is not possible to view them and customer later confirmed that videos in their possession was damaged.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 - one (1) retain sample unit was visually inspected: dispenser box and contents were in good condition, tray sealing area was complete, and no defect was observed on the sponge.Medical assessment - based on the information available, a medical assessment was performed which concludes the following: ¿the information contained within the complaint is indicative of a surgical technique procedural issue and does not indicate the occurrence of a device malfunction.It is possible to roll any matrix into a ball that may adhere to itself as it would the dura, should a matrix be manipulated in such a manner.¿.Root cause - based on the information available and the medical assessment provided, the root cause for the reported event is most likely due to a surgical technique issue and not a device malfunction.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: DURAGEN PLUS DURAL REGENERATION MATRIX 2X2 1 PA
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1100 campus drive; 1100 campus drive; princeton NJ
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 1100 campus drive; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18284680
• Report Number: 1121308-2023-00040
• Device Sequence Number: 17854208
• Product Code: GXQ
• UDI-Device Identifier: 10381780023456
• UDI-Public: 10381780023456
• Combination Product (Y/N): N
• PMA/510(K) Number: K032693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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: DP1022
• Device Lot Number: 7138572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/26/2024
• Date Device Manufactured: 05/09/2023
• 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: Male