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

Model Number	DMS22
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional quality control testing of samples is pending.
Event or Problem Description
Customer reported a triangular piece of duramatrix suturable (dms) was used on a patient as a patch during original surgery suboccipital craniectomy with c1 laminectomy and duraplasty on (b)(6) 2023.Adherus was used during the initial surgery on (b)(6) 2023.Two months after surgery the scalp flap became more protuberate.Revision surgery for repair was performed (b)(6) 2024 due to patient developing a csf leak.Another dms patch was used to cover the previous patch placed in original surgery.The suture used kept ripping through the patches.Surgeon took both patches out and placed a singular new patch of dms.The same item number and lot number of the initial surgery and revision surgery were used.No delay in surgery was reported.It was not specified which surgery the "no delay" referred to.Revison procedure was completed successfully.No further information on patient status or patient outcome has been provided.
Additional Manufacturer Narrative
Additional quality control testing of reserve product showed the product met the acceptable critteria for visual inspection, thermal transition temperature and suture pull out strength.

• 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: 18990154
• Report Number: 2249852-2024-00004
• Device Sequence Number: 14202503
• Product Code: GXQ
• UDI-Device Identifier: 00813954020402
• UDI-Public: (01)00813954020402(17)250531(10)2211091121
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/21/2024

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
• Device Expiration Date: 05/31/2025
• Device Model Number: DMS22
• Device Catalogue 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: 03/01/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/21/2024
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 102 KG