MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION INTEGRA® DURAFLEX®; DURA SUBSTITUTE

Model Number	BP10608
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per clinical staff, integra duraflex patch was used during surgery.However, patched failed causing the patient to return to operating room two additional times.Integra representative aware of failures and failed to notify surgeons or [redacted].First device id #(b)(4), ref# bp10608.
Event or Problem Description
Patient underwent initial dural graft implantation using an integra duraflex suturable dural graft, model/catalog number bp10608 (6x8cm), lot number nza21430152, expiration date 1/31/2028.Fifty-nine days post-implant, the patient required a revision surgery due to a cerebrospinal fluid leak and pseudomeningocele caused by ruptured suture patch.During this first revision, the surgeon implanted a second integra duraflex suturable dural graft, model/catalog number bp10405 (4x5cm), lot number nza24360003, expiration date 4/30/2030.Fifteen days after the second patch implantation, the patient returned to the operating room for a second revision surgery.Intraoperatively, the previously implanted patch was found to be translucent and very thin, with a defect through which cerebrospinal fluid was actively leaking.The patch was removed in its entirety and replaced with a different product by the treating provider.Integra representative aware of failures and failed to notify surgeons or the medical center.
Event or Problem Description
Patient underwent initial dural graft implantation using an integra duraflex suturable dural graft, model/catalog number bp10608 (6x8cm), lot number nza21430152, expiration date 1/31/2028.Fifty-nine days post-implant, the patient required a revision surgery due to a cerebrospinal fluid leak and pseudomeningocele caused by ruptured suture patch.During this first revision, the surgeon implanted a second integra duraflex suturable dural graft, model/catalog number bp10405 (4x5cm), lot number nza24360003, expiration date 4/30/2030.Fifteen days after the second patch implantation, the patient returned to the operating room for a second revision surgery.Intraoperatively, the previously implanted patch was found to be translucent and very thin, with a defect through which cerebrospinal fluid was actively leaking.The patch was removed in its entirety and replaced with a different product by the treating provider.Integra representative aware of failures and failed to notify surgeons or honorhealth.

• Brand Name: INTEGRA® DURAFLEX®
• Common Device Name: DURA SUBSTITUTE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 109 morgan lane; plainsboro NJ 08536
• MDR Report Key: 24303407
• Report Number: 24303407
• Device Sequence Number: 9678451
• Product Code: GXQ
• UDI-Device Identifier: 10381780511359
• UDI-Public: (01)10381780511359
• 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
• 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: BP10608
• Device Catalogue Number: BP10608
• Device Lot Number: NZA21430152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• 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
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/04/2026; 03/19/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/02/2026