MAUDE Adverse Event Report: BODYCAD LABORATORY INC. FINE OSTEOTOMY

Model Number	015-410-007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient developed a postoperative surgical site infection after a fine osteotomy procedure and required hospital readmission for a washout surgery.There is currently no confirmed evidence that the device caused or contributed to the infection.The event is under internal investigation.

• Brand Name: FINE OSTEOTOMY
• Common Device Name: FINE OSTEOTOMY
• Manufacturer (Section D): BODYCAD LABORATORY 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: 23669374
• Report Number: 3012086398-2025-00004
• Device Sequence Number: 21261624
• Product Code: HRS
• UDI-Device Identifier: 00688346002317
• UDI-Public: 00688346002317
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K241356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2025

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: 01/12/2026
• Device Model Number: 015-410-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2025
• 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 Age: 51 YR
• Patient Sex: Unknown
• Patient Weight: 82 KG