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

Model Number	DMOP33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event reported was not specific to a device lot.Due to limited information, the manufacturer could not complete a full investigation.
Event or Problem Description
Post-operative infections noticed.The customer reported that they have noticed an increase in infections and they believe it may be due to the this product being used instead of the competitor product.Based on limited correspondence and information available, it is unknown if the product was removed or replaced or if there was any additional treatment executed in order to resolve the reported infection.
Additional Manufacturer Narrative
Additional information provided on 01/14/2021 from the neurosurgeon stated that "during the covid outbreak they were restricted from using antibiotic saline as well as some changes to their protocols during operations".The neurosurgeon also stated that even though "they did not conduct a study on what was going on, he doubts our dura product was the cause".There was no change to conclusions.

• 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: 11126533
• Report Number: 2249852-2021-00001
• Device Sequence Number: 677596
• Product Code: GXQ
• UDI-Device Identifier: 00813954021294
• UDI-Public: 00813954021294
• Combination Product (Y/N): N
• PMA/510(K) Number: K150825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: No Information
• Device Model Number: DMOP33
• Device Catalogue Number: DMOP33
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 01/25/2021
• 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