MAUDE Adverse Event Report: INTEGRA - PRINCETON DURAGEN 4X5 1 PACK CE; DURAL REPAIR

Catalog Number	ID4501I
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
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 after implantation of duragen 4x5 1 pack ce (id4501i), the patient became infected and reoperation was performed on (b)(6) 2025.Resin was used for cranioplasty, and the doctor is thinking about removing the resin.Patient¿s information: unknown.Current status: follow-up (infection has subsided).Primary disease: brain tumor.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11 duragen 4x5 1 pack ce (id4501i) was not returned and lot number information has not been provided; therefore, failure analysis is not possible, and device history record (dhr) cannot be reviewed.However, a medical assessment was performed to evaluate the possible relation between the reported event and product use as follows: contribution of other concomitant device(s) used in conjunction and the neurosurgical procedure itself and their possible relationship to the reported event cannot be ruled out.As per complaint, a patient of unknown age and gender had the duragen implanted on an unspecified date.The patient was reported to have a primary disease of a brain tumor.The patient was noted to have infection after procedure.Date of the incident was reported as (b)(6) 2025, reoperation was performed on (b)(6) 2025.Unknown ¿resin¿ was used for cranioplasty, and doctor was contemplating removing the ¿resin¿.There were no details provided regarding the reoperation.Patient¿s status upon follow up indicates the infection had subsided, no further information was provided by hospital, and the product will not be returned for evaluation.Therefore, the complaint report lacks any detailed patient information, timeline of events, including the timeframe of implant date to incident date, relevant patient medical history, laboratory and diagnostic test with results (including cultures, type of organism, ct scans, etc.), treatment/interventions, details surrounding the intra-operative procedure, surgical technique, specific concomitant devices (e.G.Surgical sealants) used, and post-operative care.There was no mention from the reporter of any sterility or packaging breach with the duragen at the time of the complaint report.Lot number(s) of the implanted duragen(s) was also not provided.Additional information has been requested, but to date, no further clinical information has been received from the customer.The instruction for use (ifu) for duragen® dural graft matrix states: ¿ duragen dural regeneration matrix is supplied sterile, nonpyrogenic, for single use, in double peel packages in a variety of sizes.¿ contents of the packages are guaranteed sterile and nonpyrogenic unless the package is opened or damaged.¿ rinse surgical gloves to remove any glove powder prior to handling duragen.¿ duragen should be used with caution in infection regions.¿ adverse events: possible complications can occur with any neurosurgical procedure and include cerebrospinal fluid leaks, infection delayed hemorrhage and adhesion formation.In clinical evaluations involving 1096 patients, postoperative wound infection rates for integra¿s dural regeneration matrix were reported at approximately the same rate as the control group.Based on the available information and the medical assessment provided there is insufficient information to suggest a causal relationship of the infection to the duragen.Therefore, the complaint is considered unconfirmed.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 4X5 1 PACK CE
• Common Device Name: DURAL REPAIR
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 23849408
• Report Number: 1121308-2025-00038
• Device Sequence Number: 21290912
• Product Code: GXQ
• UDI-Device Identifier: 10381780023616
• UDI-Public: 10381780023616
• Combination Product (Y/N): N
• PMA/510(K) Number: K982180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ID4501I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown