MAUDE Adverse Event Report: INTEGRA - PRINCETON DURAGEN 4X5 1 PACK CE; N/A

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	04/21/2025
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 duragen (id4501i) was implanted to a patient with tethered sacral cord syndrome.It was used to prevent adhesion of nerve and connective tissues from dura mater.Postoperatively, there was suspicion of infection and signs of infection all over the patient¿s body.There is no plan to explant the product.Conservative treatment was given to the patient.
Additional Manufacturer Narrative
The duragen 4x5 1 pack ce (id4501i) was not returned and lot number information has not been provided; therefore, a physical evaluation of the product could not be performed, and device history record (dhr) could not be reviewed.Based on the available information a medical assessment was provided which concludes the following: ¿based on the information provided and reviewed to date, there is insufficient information to suggest a causal relationship of the infection to the duragen.As per complaint, the product was implanted to a 60-year-old female patient with tethered sacral cord syndrome on (b)(6) 2025.The duragen was used to prevent adhesion of nerve and connective tissues from the dura mater.There was no issue during the implantation.Then, sometime between the end of april 2025 to the beginning of may 2025, signs of suspicion of infection were seen all over the patient¿s body.Conservative treatment was given to the patient.There was no plan to explant the duragen.Patient outcome was pending follow up.The reported complaint lacks complete patient and event information, including other relevant medical history, detailed information surrounding the event, laboratory test or imaging evaluation with results, surgical technique and post-operative care.Despite the signs of infection, which were not further explained, it was reported that there was no plan to explant the duragen product.Conservative treatment was instead given to the patient and the customer also did not provide any details as to what those treatments were.As previously stated, duragen in this complaint was reported to have been used for a patient with tethered sacral cord syndrome, which the spinal cord abnormally attached to the spinal canal.Duragen was used to prevent adhesion of nerve and connective tissues from the dura mater.The following considerations should be taken into account, as noted in the product¿s instructions for use (ifu): ¿ complications can occur with any neurosurgical procedure, including infection.¿ duragen is not designed, sold or intended for use expect as described in the indications for use and is contraindicated in the following situations: o for patients with a known history of hypersensitivity to bovine derived materials.O for repair of spinal neural tube defects; anterior spinal surgery with dural resection (e.G., transoral surgery).O should be used with caution in infected regions.¿ 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.

• Brand Name: DURAGEN 4X5 1 PACK CE
• Common Device Name: N/A
• 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: 22061110
• Report Number: 1121308-2025-00020
• Device Sequence Number: 20743029
• 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
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/25/2025
• 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 Age: 60 YR
• Patient Sex: Female