MAUDE Adverse Event Report: BODYCAD LABORATORIES INC, FINE OSTEOTOMY

Model Number 15000

Device Problems Material Fragmentation (1261); No Apparent Adverse Event (3189); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2022

Event Type  malfunction  

Event Description

The patient underwent a lateral opening wedge distal femur osteotomy (dfo) to address a valgus deformity around the knee.Additionally, the patient received a lateral femoral condyle osteochondral allograft.The dfo procedure was performed in the standard manner, and although the medial hinge cracked, it was not stabilized.The dfo osteotomy was secured with a bodycad personalized plate, and the gap was filled with a bone graft.The initial post-operative x-ray showed that the plate was well-positioned, and the screws were of the appropriate length as planned.The patient returned for a routine checkup six weeks post-op, where it was noted that one of the distal screws (d) had slightly backed out, and another screw (b) was slightly bent.However, the plate remained stable, and the micro-fracture at the hinge site was showing good consolidation.There was excellent bone healing and proper consolidation of the osteotomy, with no loss of correction.At the second routine checkup, 12 weeks post-op, no signs of infection were observed.Two screws (c and d) had backed out slightly but remained stable and had not moved beyond the locking mechanism (3 mm).All other screws' threads were within the bone structure, and there was continued excellent healing at the osteotomy site.Unfortunately, screw b had failed, but this was discovered during the routine checkup and did not cause any painful issues necessitating immediate revision surgery.Despite these developments, the structure remained stable, aided by the strong bone healing.As a result, no revision surgery was recommended.The patient's hardware removal was scheduled as initially planned, and there were no reported complications during this procedure.

• Brand Name: FINE OSTEOTOMY
• Type of Device: FINE OSTEOTOMY
• Manufacturer (Section D): BODYCAD LABORATORIES INC,; 2035 rue du haut-bord; quebec, quebec G1N 4 R7; CA G1N 4R7
• Manufacturer Contact: nadine adia ; 2035 rue du haut-bord; quebec, quebec G1V 3-Y6 ; CA G1V 3Y6
• MDR Report Key: 17950052
• MDR Text Key: 325862527
• Report Number: 3012086398-2023-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00688346002140
• UDI-Public: 00688346002140
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2023

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
• Device Expiration Date: 12/18/2022
• Device Model Number: 15000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 93 KG