MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. COPIOS EXTEND; COLLAGEN DENTAL MEMBRANE V

Model Number 0191Z

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

Initial submission was inadvertently submitted to the fda webtrader test account.

Event Description

It was reported that a doctor noted at #12 extration with a severe buccal defect patient and was placed on antibiotics for 7 days prior to surgery and continued for 3 days.Bone material was placed with copios membrane complete covering of the bone and extracted site with sutures.The following week, the membrane had completely dissolved and the major bone material had dislodged from the site.

• Brand Name: COPIOS EXTEND
• Type of Device: COLLAGEN DENTAL MEMBRANE V
• 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: 13358477
• MDR Text Key: 289286913
• Report Number: 2249852-2021-00011
• Device Sequence Number: 1
• Product Code: NPL
• UDI-Device Identifier: 00813954020549
• UDI-Public: 00813954020549
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2022
• Device Model Number: 0191Z
• Device Catalogue Number: 0191Z
• Device Lot Number: PDMU20H1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other