MAUDE Adverse Event Report: COLLAGEN MATRIX, INC DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE

Model Number	CDSM22
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Quality control testing on reserve samples confirmed that the product met release acceptance criteria.
Event or Problem Description
Limited information from the customer was provided.The customer stated that during a surgery on (b)(6) 2023, duramatrix product tore as pa was suturing.Intervention surgery required two-weeks post-op to repair.Additional information was requested from the customer, including patient status and nature of the surgery/event, however information was not provided.Patient impact and any additional information about the surgery and patient was also requested but not provided.No further information was provided.

• Brand Name: DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
• Common Device Name: DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC; 15 thornton rd; 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: 16620458
• Report Number: 2249852-2023-00010
• Device Sequence Number: 17641239
• Product Code: GXQ
• UDI-Device Identifier: 00813954020204
• UDI-Public: (01)00813954020204(17)250228(10)2202172022
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2023

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: 02/28/2025
• Device Model Number: CDSM22
• Device Lot Number: 2202172022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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
• Patient Sex: Unknown