MAUDE Adverse Event Report: MICROAIRE SURGICAL INSTRUMENTS ENDOTINE FOREHEAD 3.5

Model Number	CFD-22102
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer states right brow dropped several days after surgery on (b)(6) 2026.A second surgery to replace endotine was done on (b)(6) 2026.

• Brand Name: ENDOTINE FOREHEAD 3.5
• 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; 3590 grand forks blvd; charlottesville VA 22911
• MDR Report Key: 25304420
• Report Number: 2020601-2026-00004
• Device Sequence Number: 13085033
• Product Code: ODU
• UDI-Device Identifier: 00847399006851
• UDI-Public: 00847399006851
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CFD-22102
• Device Catalogue Number: CFD-22102
• Device Lot Number: 437425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2026
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 93 KG