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

Model Number	DMS33
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that a patient had a csf leak and the clinician went back in to repair.The clinician noticed there was a tear in the middle of the graft.The tear was sutured and dmop was placed on top.The site still leaked so a shunt was placed on the patient to circumvent the issue.

• Brand Name: DURAMATRIX SUTURABLE
• Common Device Name: COLLAGEN DURA MEMBRANE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 11858404
• Report Number: 2249852-2021-00006
• Device Sequence Number: 4016745
• Product Code: GXQ
• UDI-Device Identifier: 00813954020419
• UDI-Public: 00813954020419
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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
• Operator of Device: No Information
• Device Expiration Date: 08/31/2022
• Device Model Number: DMS33
• Device Catalogue Number: DMS33
• Device Lot Number: 2002201121
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention