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

Model Number	0190Z
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Limited information was provided.Customer reported the copios extend membrane overall is hard to secure.Patient came back for post-op and the membrane wasn't there and this was two weeks after initial surgery.A delay in surgery was indicated since the implant was removed and the patient needs to heal before the 2nd attempt.No indication of impact to patient was reported.Additional information on patient outcome was requested, but not provided.

• Brand Name: COPIOS EXTEND MEMBRANE
• 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: 20398490
• Report Number: 2249852-2024-00024
• Device Sequence Number: 3351601
• Product Code: NPL
• UDI-Device Identifier: 00813954020532
• UDI-Public: 00813954020532
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2024

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: 10/31/2025
• Device Model Number: 0190Z
• Device Catalogue Number: 0190Z
• Device Lot Number: PDMU23M1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2023
• 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
• Patient Sex: Unknown