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

Model Number	DMS33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Meningitis (2389)
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical data collection site reported patient had csf leak and meningitis after duramatrix suturable placement.The patient returned to the or for tumor resection and wound revision 2 months postop (repeating use of the duramatrix suturable).The patient returned to the or again 5 months postop for shunt placement and repeat wound revision.The complainant stated the csf leak was related to the patient's unerlying hydrocephalus and was not related to a technical or material issue.There were multiple devices used, including duramatrix suturable as inlay and a nonsuturable duramatrix as onlay, then glue across reconstruction.No additional information was provided on patient status or patient outcome.
Additional Manufacturer Narrative
Qc testing was performed at the time of product release and produced results that met all acceptance critiera.

• Brand Name: DURAMATRIX SUTURABLE
• Common Device Name: COLLAGEN DURA MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC; 15 thornton rd; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC; 15 thornton rd; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 15125067
• Report Number: 2249852-2022-00028
• Device Sequence Number: 17546440
• Product Code: GXQ
• UDI-Device Identifier: 00813954020419
• UDI-Public: 00813954020419
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2022

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?: No
• Device Expiration Date: 08/31/2022
• Device Model Number: DMS33
• Device Catalogue Number: DMS33
• Device Lot Number: 2002041121
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2020
• 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