MAUDE Adverse Event Report: BODYCAD LABORATORIES, INC FINE OSTEOTOMY

Model Number	015000
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A high tibial osteotomy (hto) was performed using the fine osteotomy system approximately 5 months ago, resulting in a nonunion, indicating a lack of proper bone healing.The limb now shows a varus deviation, along with hardware loosening.

• Brand Name: FINE OSTEOTOMY
• Common Device Name: FINE OSTEOTOMY
• Manufacturer (Section D): BODYCAD LABORATORIES, INC; 2035 rue du haut-bord; quebec, quebec G1N4R 7; CA G1N4R7
• Manufacturer (Section G): BODYCAD LABORATORIES INC.; 2035 rue du haut-bord; quebec, quebec G1N4R 7; CA G1N4R7
• Manufacturer Contact: nadine adia ; 2035 rue du haut-bord; quebec, quebec G1N4R-7 ; CA G1N4R7
• MDR Report Key: 20540231
• Report Number: 3012086398-2024-00001
• Device Sequence Number: 15508648
• Product Code: HRS
• UDI-Device Identifier: 00688346002287
• UDI-Public: 00688346002287
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K240703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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: 10/09/2024
• Device Model Number: 015000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2024
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 66 KG