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 Codes	Drug Resistant Bacterial Infection (4553); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was provided.Clinical data collection site reported the patient underwent surgery for a right parieto-occipital craniotomy.Duramatrix onlay plus (dmop) was used during surgery (surgery date not provided).Patient developed perforated diverticulitis 4 days following the initial surgery, resulting in the need for sigmoid colectomy and ostomy creation.The perforated diverticulitis may have contributed "to odd presentation of delayed and deep wound infection with mrsa" at 7 weeks post op.Also at 7 weeks postop, patient required wound washout including craniectomy and dmop removal for superficial and deep would infection.The patient also received gamma knife radiation one month postop.No further event information or information related to patient status or patient outcome was provided.
Additional Manufacturer Narrative
Additional quality control testing of samples is pending.
Additional Manufacturer Narrative
Additional quality control testing of reserve product 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: 17683330
• Report Number: 2249852-2023-00016
• Device Sequence Number: 6351117
• Product Code: GXQ
• UDI-Device Identifier: 00813954021294
• UDI-Public: (01)00813954021294(10)240731(17)2107141022
• 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: 07/31/2024
• Device Model Number: DMOP33
• Device Catalogue Number: DMOP33
• Device Lot Number: 2107141022
• 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: 07/31/2021
• 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 Sex: Unknown