MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX ONLAY; DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE

Model Number	CDSLM45
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.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
It was initially reported that the duramatrix onlay (cdslm45) product in combination with duramatrix suturable (dms45; emdr report 2249852-2017-00017) was used as part of a post area fossa craniotomy procedure which resulted in follow-up surgery to fix a cerebrospinal fluid leak.Based on additional information received on 10/11/2018, it has been determined that the duramatrix onlay (cdsml45) product was not used or associated with the initially reported incident.
Additional Manufacturer Narrative
Contrary to the initial report, it has been determined that the subject device of this report (duramatrix onlay cdslm45) was not involved in the reported incident.

• Brand Name: DURAMATRIX ONLAY
• Common Device Name: DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 6915042
• Report Number: 2249852-2017-00018
• Device Sequence Number: 16264098
• Product Code: GXQ
• UDI-Device Identifier: 00813954020273
• UDI-Public: 00813954020273
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K061487
• 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: 03/31/2019
• Device Model Number: CDSLM45
• Device Lot Number: 1703033023
• 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: 09/13/2017
• 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 SUTURABLE.; DURAMATRIX SUTURABLE
• Outcome Attributed to Adverse Event: Required Intervention