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

Catalog Number	DMS22
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Permeability testing was performed on a reserve sample.Results met acceptance criteria.
Event or Problem Description
Patient experienced post-operative cerebrospinal fluid leak and infection.The surgery will be performed again and the device will be explanted.

• 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: 5481091
• Report Number: 2249852-2016-00005
• Device Sequence Number: 13536072
• Product Code: GXQ
• UDI-Device Identifier: 00813954020402
• UDI-Public: 00813954020402
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2016

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: 02/29/2016
• Device Catalogue Number: DMS22
• Device Lot Number: 1508181121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2016
• Initial Report FDA Received Date: 03/04/2016
• 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