MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEMS; FIBULA CUTTING GUIDE

Model Number	Fibula Cutting Guide
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a maxillofacial reconstructive surgery, it was reported that the posterior cut on the fibula resulted in a fibula segment approximately 2mm longer than was required.This caused a misalignment between the predictive holes and the custom reconstruction plate.To rectify the issue, the fibula was adjusted by removing small pieces of the fibula segment, resulting in a successful reconstruction of the mandible.Subsequently, the predictive holes were re-drilled in the fibula segment to account for the removal of bone.This led to an estimated delay of 25 minutes.

• Brand Name: VSP SYSTEMS
• Common Device Name: FIBULA CUTTING GUIDE
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 south alkire circle; littleton, CO 80127 ; 7206431011
• MDR Report Key: 16788150
• Report Number: 1724955-2023-00010
• Device Sequence Number: 5733696
• Product Code: DZJ
• UDI-Device Identifier: 00816847020794
• UDI-Public: (01)00816847020794(10)
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K192192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: Fibula Cutting Guide
• Device Catalogue Number: VSPR-500
• 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: 03/23/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• 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: 45 YR
• Patient Sex: Female