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

Model Number	DMS45
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record review and additional qc reserve sample testing confirms that the product met release criteria.There are no indications that the product would not perform as designed.
Event or Problem Description
The clinician reported that a revision surgery was performed as a result of csf leak 11 days following the initial post area fossa craniotomy.The initial procedure was completed using a combination of duramatrix suturable and duramatrix onlay products.During the revision surgery the clinician observed that the duramatrix suturable product was breaking down on the edges.Based on additional feedback provided, the suturing technique during the initial procedure may have been a contributing factor in the event.
Event or Problem Description
The clinician reported that a revision surgery was performed as a result of csf leak 11 days following the initial post area fossa craniotomy.During the revision surgery the clinician observed that the duramatrix suturable product was breaking down on the edges and had a small amount of fluid buildup underneath.As part of the initial reporting the distributor's sales representative stated that duramatrix suturable product was used in conjunction with duramatrix onlay product (emdr report 2249852-2017-00018).Based on follow-up information it has been determined that duramatrix suturable product was the only product used in the procedure and the duramatrix onlay product was not involved.
Additional Manufacturer Narrative
Based on the additional information received from the distributor and clinician section has be updated.It has been clarified that the duramatrix suturable (dms45) product was the only product associated with the reported incident and the duramatrix onlay product was not used.

• Brand Name: DURAMATRIX SUTURABLE
• Common Device Name: COLLAGEN DURA MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 6914978
• Report Number: 2249852-2017-00017
• Device Sequence Number: 19193521
• Product Code: GXQ
• UDI-Device Identifier: 00813954020426
• UDI-Public: 00813954020426
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: DMS45
• Device Lot Number: 1610131121
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DURAMATRIX ONLAY; DURAMATRIX ONLAY
• Outcome Attributed to Adverse Event: Required Intervention