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

Catalog Number	DMS33
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reported that during surgery, there was leaking observed in the middle of the implant.There was an additional product used to stop the leak.It is unknown if the leak was a csf leak.There were no surgical delays or any adverse events associated with this event.

• Common Device Name: COLLAGEN DURA MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 8633220
• Report Number: 2249852-2019-00013
• Device Sequence Number: 1655716
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: DMS33
• Device Lot Number: 1808171121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other