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

Catalog Number	DMOP45
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional testing of qc reserve samples is on-going.
Event or Problem Description
It was reported, that a customer performed a surgery on a large meningioma and used the product to repair the dural defect.The patient returned as he was deteriorating and it turned out that there was an infection in the dural graft, which was later determined to be a p acnes infection.The infection seemed to be held in the middle of the graft.It is unknown if the product was removed or replaced.
Event or Problem Description
It was reported, that a customer performed a surgery on a large meningioma and used the product to repair the dural defect.The patient returned as he was deteriorating and it turned out that there was an infection in the dural graft, which was later determined to be a p acnes infection.The infection seemed to be held in the middle of the graft.It is unknown if the product was removed or replaced.
Additional Manufacturer Narrative
Additional testing of qc reserve samples met acceptance criteria.

• Common Device Name: COLLAGEN DURAL REGENERATION MATRIX
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 8719706
• Report Number: 2249852-2019-00014
• Device Sequence Number: 16662387
• Product Code: GXQ
• UDI-Device Identifier: 00813954021300
• UDI-Public: 00813954021300
• Combination Product (Y/N): N
• PMA/510(K) Number: K150825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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: 06/30/2020
• Device Catalogue Number: DMOP45
• Device Lot Number: 1806063023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/08/2019
• 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: Hospitalization; Required Intervention