MAUDE Adverse Event Report: BODYCAD LABORATORIES, INC FINE OSTEOTOMY; PLATE, FIXATION, BONE. SCREW, FIXATION, BONE.

Model Number	015-000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Screws backing up.During a routine appointment, the doctor noticed on the x-ray that 3 screws were migrating.No infection is present.Note also that we see a fracture on the opposite side of the cortex.We see a small fracture initiation on the post-op photo and it seems to have worsened on the 6 week post-op photo.
Additional Manufacturer Narrative
During a routine appointment, the doctor noticed on the x-ray that 3 screws were migrating.The screws that have migrated are the screws at position d, e and f.No infection is present.No infection is present.Also we see a fracture on the opposite side of the cortex.A second surgery was performed to remove two of the three screws in place and one screw was re-screwed.Investigation could not be completed, no device was returned.However , it was noted that the device had no defect and review of the device history record indicates that the device was manufactured to specifications.The event was not caused by wrong labeling or wrong instructions for use.Bodycad considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened and a follow-up medical device report will be filed accordingly.

• Brand Name: FINE OSTEOTOMY
• Common Device Name: PLATE, FIXATION, BONE. SCREW, FIXATION, BONE.
• Manufacturer (Section D): BODYCAD LABORATORIES, INC; 2035 rue du haut-bord; quebec, G1N 4 R7; CA G1N 4 R7
• Manufacturer Contact: nadine adia ; 2035 rue du haut-bord; quebec, quebec G1N 4-R7 ; CA G1N 4R7
• MDR Report Key: 15792648
• Report Number: 3012086398-2022-00001
• Device Sequence Number: 5850634
• Product Code: HRS
• UDI-Device Identifier: 00688346002140
• UDI-Public: 00688346002140
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 211646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Repair,Replace
• Type of Report: Initial
• Report Date (Section B): 11/09/2022

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
• Device Expiration Date: 01/04/2023
• Device Model Number: 015-000
• Device Catalogue Number: 015-330-007
• 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: 11/14/2022
• Initial Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 94 KG