MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. DURAMATRIX ONLAY PLUS; COLLAGEN DURAL REGENERATION MATRIX

Model Number	DMOP33
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A revision surgery was performed 2-3 weeks following the initial craniotomy procedure where duramatrix onlay plus product was implanted.During the revision surgery the surgeon observed a hole in the canter of the duramatrix onlay plus product.It is unknown how the surgeon fixed the issue or if any adverse effects occured.Following further communications, the surgeon concluded that the hole most likely occurred due to surgical technique rather than device problem.

• Brand Name: DURAMATRIX ONLAY PLUS
• Common Device Name: COLLAGEN DURAL REGENERATION MATRIX
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 6648478
• Report Number: 2249852-2017-00013
• Device Sequence Number: 1150512
• Product Code: GXQ
• UDI-Device Identifier: 00813954021294
• UDI-Public: 00813954021294
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K150825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: DMOP33
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1