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

Model Number	DMS33
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	09/19/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Following initial surgery on (b)(6) 2016 a revision surgery was performed on (b)(6) 2016 due to cerebrospinal fluid leak.During the attempt to repair the leak in the original implant, the implant tore and shredded.The original implant was removed and replaced with a new membrane.

• 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: 6060991
• Report Number: 2249852-2016-00015
• Device Sequence Number: 13561400
• Product Code: GXQ
• UDI-Device Identifier: 00813954020419
• UDI-Public: 00813954020419
• Combination Product (Y/N): N
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2016

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: 05/31/2017
• Device Model Number: DMS33
• Device Lot Number: 1605231121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2016
• Initial Report FDA Received Date: 10/27/2016
• 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: Required Intervention