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

Model Number	DMOP57
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinician used a duramatrix onlay plus product that was approximately 1 month past its expiration date to complete an emergency cranitomy/ craniectomy as it was the only available product on the shelf.

• 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: 8214852
• Report Number: 2249852-2019-00001
• Device Sequence Number: 11259579
• Product Code: GXQ
• UDI-Device Identifier: 00813954021317
• UDI-Public: 00813954021317
• Combination Product (Y/N): N
• PMA/510(K) Number: K150825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2019

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: Health Professional
• Device Model Number: DMOP57
• Device Lot Number: 1610283023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 01/03/2019
• 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
• Patient Age: 72 YR