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

Model Number	CDSLM33
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgeon used duramatrix during a suboccipital craniectomy and reported that the dura substitute dissolved and they had to remove it and place a lumbar drain.Since there was not a tight seal using the duramatrix, csf was able to leak through.The product was replaced with duragen and discarded.

• Brand Name: DURAMATRIX ONLAY
• Common Device Name: COLLAGEN DURA SUBSTITUTE MEMBRANE
• 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: 14113830
• Report Number: 2249852-2022-00002
• Device Sequence Number: 16668140
• Product Code: GXQ
• UDI-Device Identifier: 00813954020266
• UDI-Public: 00813954020266
• Combination Product (Y/N): N
• PMA/510(K) Number: K061487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2022

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?: Yes
• Device Expiration Date: 01/31/2024
• Device Model Number: CDSLM33
• Device Catalogue Number: CDSLM33
• Device Lot Number: 2101272022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2021
• 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 Sex: Unknown