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

Model Number	CDSM22
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial surgery for a chiari malformation with duramatrix on (b)(6) 2024.The patient was brought back on (b)(6) 2024 for a csf leak due to "graft failure".It was noted during the revision surgery the duramatrix graft had a tear.Customer believes tear was from the initial surgery.The clinician reported a surgical delay but the time of delay was not provided, only that the patient was brought back to do a shunt and revise the initial chiari malformation surgery.It was also reported that a dural sealent adherus was used.Adherus is not a collagen matrix, inc.Product.No issues on adverse events reported after revision surgery.No further information provided on patient status or patient outcome.
Additional Manufacturer Narrative
Additional quality control testing of reserve product showed the product met acceptance criteria for visual inspection, thermal transition temperature testing and suture pull out strength testing.

• Brand Name: DURAMATRIX
• Common Device Name: DURAMATRIX COLLAGEN DURA SUBSTITUTE
• 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: 19615809
• Report Number: 2249852-2024-00011
• Device Sequence Number: 6112421
• Product Code: GXQ
• UDI-Device Identifier: 00813954020204
• UDI-Public: (01)00813954020204(17)260331(10)2303221022
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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: 03/31/2026
• Device Model Number: CDSM22
• Device Catalogue Number: CDSM22
• Device Lot Number: 2303221022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female