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

Model Number	DMOP57
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
Additional quality control testing of samples is pending.
Event or Problem Description
Limited information was provided.Clinical data collection site reported the patient suffered an early wound infection 8 days postop after duramatrix onlay plus (dmop) was used in a surgery (type of surgery and date of surgery not specified).Revision surgery was required for wound washout.During the revision surgery, the dmop graft was replaced with another dmop graft, but "only because the prior graft [from the initial surgery] was explored for infection." it was noted the initial dmop graft was not to be involved and there was no issue with the initial dmop graft that was placed.No additional event or patient information provided.
Additional Manufacturer Narrative
Additional quality control testing of devices retained by the manufacturer showed the product met acceptable sterility and ph 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: 17683331
• Report Number: 2249852-2023-00015
• Device Sequence Number: 6351118
• Product Code: GXQ
• UDI-Device Identifier: 00813954021317
• UDI-Public: (01)00813954021317(10)240430(17)2104142023
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• 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: 04/30/2024
• Device Model Number: DMOP57
• Device Catalogue Number: DMOP57
• Device Lot Number: 2104141023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• 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: 05/30/2021
• 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: Required Intervention; Other
• Patient Sex: Unknown