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

Model Number	0191Z
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial submission was inadvertently submitted to the fda webtrader test account.
Event or Problem 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 majority of the bone material had dislodged from the site.

• Brand Name: COPIOS EXTEND
• Common Device Name: 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: 13358478
• Report Number: 2249852-2021-00012
• Device Sequence Number: 4737983
• Product Code: NPL
• UDI-Device Identifier: 00813954020549
• UDI-Public: 00813954020549
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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: Other
• Patient Sex: Unknown