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

Model Number	DMS22
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported the duramatrix suturable product was placed in patient for a chiari malformation procedure on (b)(6) 2023.The patient was brought back to surgery, and the surgeon stated that the perimeter of the graft was still sutured to the native dura, but when gently manipulated with an instrument the graft "fell apart." customer did not specify the reason why the patient was brought back to surgery.Date of additional surgery was not provided.Additional information was requested, including the reason for why the patient was brought back for surgery, if the procedure(s) were completed successfully, if there were any delays in procedure(s), the current patient status, and if any additional follow-up surgeries were required.No additional event or patient information provided.
Additional Manufacturer Narrative
Additional quality control testing of samples is pending.
Additional Manufacturer Narrative
Additional quality control testing of reserve product showed the product met the acceptable criteria for suture pull-out strength testing and thermal transition determination.

• 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: 17907116
• Report Number: 2249852-2023-00018
• Device Sequence Number: 7822902
• Product Code: GXQ
• UDI-Device Identifier: 00813954020402
• UDI-Public: (01)00813954020402(17)250331(10)2211091121
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/19/2023

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
• Device Expiration Date: 03/31/2025
• Device Model Number: DMS22
• Device Lot Number: 2211091121
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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 Sex: Unknown