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

Model Number	DMOP33
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional quality control testing of samples is pending.
Event or Problem Description
Limited information was provided.Clinical data collection site reported patient underwent surgery most recently on (b)(6) 2021 for a right frontal craniotomy.The duramatrix onlay plus (dmop) was placed during this operation.Patient suffered a delayed post-op hematoma that required evacuation on (b)(6) 2021.Clinician replaced the dmop that was placed during the first operation with a second set of dmop during the second surgery.There were no reported complaints or further adverse events after the second surgery where the second dmop product was utilized.The patient received immunotherapy postop.No additional information on patient status or patient outcome was provided.
Additional Manufacturer Narrative
Additional quality control testing of devices retained by the manufacturer showed the product met acceptable sterility, ph, and liquid permeability criteria.

• Brand Name: DURAMATRIX-ONLAY PLUS
• Common Device Name: COLLAGEN DURAL REGENERATION MATRIX
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 17683329
• Report Number: 2249852-2023-00013
• Device Sequence Number: 6351116
• Product Code: GXQ
• UDI-Device Identifier: 00813954021294
• UDI-Public: (01)00813954021294(17)240229(10)2102272023
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K150825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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
• Device Expiration Date: 02/29/2024
• Device Model Number: DMOP33
• Device Catalogue Number: DMOP33
• Device Lot Number: 2102272023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male