MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION INTEGRA® BOVINE PERICARDIUM DURAL GRAFT; DURA SUBSTITUTE

Model Number	BP10405
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per surgical staff, integra duraflex patch used for case but patch disintegrated causing the patient to have revision surgery.Integra rep knew about the issue and never notified the surgeon or [redacted].Device id number is (b)(4).Ref# bp10405.Serial #[redacted].
Event or Problem Description
Per surgical staff, integra duraflex patch used for case but patch disintegrated causing the patient to have revision surgery.Integra rep knew about the issue and never notified the surgeon or [redacted].Device id number is 10381780511342.Ref# (b)(4).Serial #[redacted].
Event or Problem Description
Patient underwent initial dural graft implantation using an integra duraflex suturable dural graft, model/catalog number bp10405 (4x5cm), lot number nza24360003, expiration date 4/30/2030.Thirty-four days post-implant, the patient was taken back to the operating room for diagnosis of a cerebrospinal fluid leak and pseudomeningocele.Intraoperatively, the edges of the patch appeared to be disintegrating in certain areas and cerebrospinal fluid could be seen coming out.Those points were sutured again to the dura and multiple valsalva maneuvers were performed, with no further cerebrospinal fluid leak identified.The suture line was augmented with surgical glue.Fifty-seven days after the initial implantation, the patient returned to the operating room for a second revision surgery.During this procedure, the previously implanted patch was no longer white but translucent and had a hole in the patch with egress of cerebrospinal fluid.The patch was removed in its entirety and replaced with a different product by the treating provider.Integra rep knew about the issue and never notified the surgeon or the medical center.
Event or Problem Description
Patient underwent initial dural graft implantation using an integra duraflex suturable dural graft, model/catalog number bp10405 (4x5cm), lot number nza24360003, expiration date 4/30/2030.Thirty-four days post-implant, the patient was taken back to the operating room for diagnosis of a cerebrospinal fluid leak and pseudomeningocele.Intraoperatively, the edges of the patch appeared to be disintegrating in certain areas and cerebrospinal fluid could be seen coming out.Those points were sutured again to the dura and multiple valsalva maneuvers were performed, with no further cerebrospinal fluid leak identified.The suture line was augmented with surgical glue.Fifty-seven days after the initial implantation, the patient returned to the operating room for a second revision surgery.During this procedure, the previously implanted patch was no longer white but translucent and had a hole in the patch with egress of cerebrospinal fluid.The patch was removed in its entirety and replaced with a different product by the treating provider.Integra rep knew about the issue and never notified the surgeon or (b)(6).

• Brand Name: INTEGRA® BOVINE PERICARDIUM DURAL GRAFT
• Common Device Name: DURA SUBSTITUTE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 109 morgan lane; plainsboro NJ 08536
• MDR Report Key: 24303371
• Report Number: 24303371
• Device Sequence Number: 5215043
• Product Code: GXQ
• UDI-Device Identifier: 10381780074229
• UDI-Public: (01)10381780074229
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/02/2026
• Report Date (Section F): 02/02/2026

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
• Device Model Number: BP10405
• Device Catalogue Number: BP10405
• Device Lot Number: NZA24360003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/10/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 02/25/2026; 03/04/2026; 03/19/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/02/2026