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	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial submission was inadvertently submitted to the fda webtrader account.
Event or Problem Description
It was reported that a doctor noted at #12 tooth extraction, # 13 implants placed on same day no abcess 50 n torque achieved.Bone material and copios membrane covered both implants.At the two week follow up, the membrane completely dissolved and bone dislodged.No abcess.

• 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: 13358109
• Report Number: 2249852-2021-00010
• Device Sequence Number: 4646402
• 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