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	Cerebrospinal Fluid Leakage (1772)
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was provided.Clinical data collection site reported a patient required "takeback surgery 8 days postop for endoscopic endonasal csf leak repair." the patient had initially underwent resection of large skull base mass invading the infratemporal fossa and paranasal sinuses, with a planned free flap placement the next day (date of surgeries not provided).Duramatrix onlay plus (dmop) was placed over the anterior temporal lobe along with fibrin glue and a free pericranial graft in a non-watertight fashion to complete a non-rigid closure in anticipation of the free flap placement (which was supposed to be the next day).The free flap placement was supposed to "obliterate the dead space in the extracranial compartment/paranasal sinuses to obliterate any potential csf fistula." the takeback surgery was performed 8-days postop, and showed the dmop graft was in an unchanged position and placed as intended.Clinician confirmed the "csf leak was caused by failure of free flap placement, not intracranial reconstruction including the dmop graft." patient received postoperative radiation and chemotherapy.Further information on postoperative care was not provided and the dates of the radiation and chemotherapy treatments were not provided.No further information provided on patient outcome or patient status.

• 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: 17670940
• Report Number: 2249852-2023-00014
• Device Sequence Number: 20414163
• Product Code: GXQ
• UDI-Device Identifier: 00813954021294
• UDI-Public: (01)00813954021294(10)240531(17)2105242023
• 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
• Report Date (Section B): 09/01/2023

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: 05/31/2024
• Device Model Number: DMOP33
• Device Catalogue Number: DMOP33
• Device Lot Number: 2105242023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 69 YR
• Patient Sex: Male