MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS MICROAIRE ENDOTINE; ENDOTINE FOREHEAD 3.5

Model Number	CFD-22102
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The female patient had a cfd-22102 endotine forehead 3.5 lot # 351185 implanted on (b)(6) 2020 and later found that the implant did not hold the soft tissue securely.Customer states they feel the fixation was loose and requested a revision of the procedure.
Event or Problem Description
Endotine forehead 3.5 lot 351185 was placed on (b)(6) 2020 did not hold the soft tissue securely and tightly.Docotr found that the implant did not hold the soft tissue securely.It meant that the fixation was loose and patient requested a re-do procedure and implanted another 22102 lot # 354742 on (b)(6) 2021 and the operation was done successfully.
Event or Problem Description
Endotine forehead 3.5 lot 3 351185 was placed on (b)(6) 2022 did not hold the soft tissue securely and tightly.Docotr found that the implant did not hold the soft tissue securely.It meant that the fixation was loose and patient requested a re-do procedure and implanted another 22102 lot # 354742 on (b)(6) 2021 and the operation was done successfully.

• Brand Name: MICROAIRE ENDOTINE
• Common Device Name: ENDOTINE FOREHEAD 3.5
• Manufacturer (Section D): MICROAIRE SURGICAL INSTRUMENTS; 3590 grand forks blvd; charlottesville VA 22911
• Manufacturer (Section G): MICROAIRE SURGICAL INSTRUMENTS, LLC; 3590 grand forks blvd.; charlottesville VA 22911
• Manufacturer Contact: erin knight ; 3590 grand forks blvd; charlottesville, VA 22911 ; 4349758389
• MDR Report Key: 11350576
• Report Number: 2020601-2021-00001
• Device Sequence Number: 4502804
• Product Code: ODU
• UDI-Device Identifier: 10847399006858
• UDI-Public: 10847399006858
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K032270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2023
• Device Model Number: CFD-22102
• Device Catalogue Number: CFD-22102
• Device Lot Number: 351185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/25/2021; 02/25/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 02/10/2022; 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female