MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX SUTURABLE; COLLAGEN DURA MEMBRANE

Model Number	DMS33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Quality control testing on reserve samples confirmed that the product met acceptance criteria for visual inspection, thermal transition temperature and suture pull out strength testing.
Event or Problem Description
It was reported by the surgeon that two weeks pot-op, the patient presented with a csf leak and a revision surgery was performed.During the revision surgery the surgeon found the patch was completely disintegrated.No issues on adverse events reported after revision surgery.The exact date of the revision surgery was not provided.No further information provided on patient status or patient outcome.
Event or Problem Description
It was reported by the surgeon that two weeks post-op, the patient presented with a csf leak and a revision surgery was performed.No information surrounding initial surgery (date of initial surgery not provided).The patient was admitted to the hospital from on (b)(6) 2024 due complications directly related to the duramatrix suturable product.During the revision surgery the surgeon found the patch was completely disintegrated.The patient now has ventriculoperitoneal (vp) shunt.Discharged with follow up on (b)(6) 2024 for sedated brain mri and suture removal.Adherus was also used during the procedure (lot no.11235216) but it is unclear if it was used during the initial surgery or the revision surgery.Adherus is a dural sealant and is not manufactured by collagen matrix, inc.The exact date of the revision surgery was not provided.No further information provided on patient status or patient outcome.
Additional Manufacturer Narrative
The original reported event date of 05/23/2024 is unclear as it was not specified whether this was the initial surgery or the revision surgery date.

• Brand Name: DURAMATRIX SUTURABLE
• Common Device Name: COLLAGEN DURA MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 19615819
• Report Number: 2249852-2024-00012
• Device Sequence Number: 17670300
• Product Code: GXQ
• UDI-Device Identifier: 00813954020419
• UDI-Public: (01)00813954020419(17)260131(10)2307212121
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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 Expiration Date: 01/31/2026
• Device Model Number: DMS33
• Device Catalogue Number: DMS33
• Device Lot Number: 2307212121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 10 YR
• Patient Sex: Male