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

Model Number	CDSLM33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgeon observed a csf leak through the dmo in posterior fossa.The surgeon was able to complete the procedure using another product.There was no delay in procedure reported.

• Brand Name: DURAMATRIX-ONLAY
• Common Device Name: COLLAGEN DURA SUBSTITUTE MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland, nj
• MDR Report Key: 9706844
• Report Number: 2249852-2020-00002
• Device Sequence Number: 14308339
• Product Code: GXQ
• UDI-Device Identifier: 00813954020266
• UDI-Public: 00813954020266
• Combination Product (Y/N): N
• PMA/510(K) Number: K061487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: No Information
• Device Expiration Date: 04/30/2022
• Device Model Number: CDSLM33
• Device Catalogue Number: CDSLM33
• Device Lot Number: 1904172022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other