MAUDE Adverse Event Report: BODYCAD LABORATORIES, INC. FINE OSTEOTOMY

Model Number	015-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a hardware removal procedure, two bone screws were found to be fractured.The event was identified intraoperatively during explantation of a previously implanted system.Imaging prior to removal had not clearly indicated breakage.Some screw fragments remained in situ.The procedure was otherwise completed, and the patient is reported to be doing well.

• Brand Name: FINE OSTEOTOMY
• Common Device Name: FINE OSTEOTOMY
• Manufacturer (Section D): BODYCAD LABORATORIES, INC.; 2035 rue du haut-bord,; quebec, quebec G1N 4 R7; CA G1N 4R7
• Manufacturer (Section G): BODYCAD LABORATORIES INC.; 2035 rue du haut-bord; quebec, quebec ; CA
• Manufacturer Contact: nadine adia ; 2035 rue du haut-bord; quebec, quebec G1N 4-R7 ; CA G1N 4R7
• MDR Report Key: 24793545
• Report Number: 3012086398-2026-00001
• Device Sequence Number: 13222748
• Product Code: HWC
• UDI-Device Identifier: 00688346002287
• UDI-Public: 00688346002287
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K253300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

1 Device was Involved in the Event

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: 03/07/2023
• Device Model Number: 015-000
• 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: Not provided
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Male