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

Model Number Fibula Cutting Guide

Device Problems Labelling, Instructions for Use or Training Problem (1318); Inaccurate Information (4051)

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

Event Date 09/01/2021

Event Type  Injury  

Event Description

For a vsp reconstruction procedure, the surgeon identified the following issues: the vsp reconstruction surgical plan documented on the 3d systems case report provided to the surgeon did not align with the virtual simulated plan.The surgical procedure was documented as left fibula to right neck; instead of right fibula to right neck.This issue was identified by the surgeon prior to surgery.3d systems verified that the manufactured anatomical fibula cutting guide was designed to the correct right fibula right neck surgical plan; and the issue was isolated to a case report documentation error.3d systems corrected the case report and submitted a new revision to the surgeon prior to surgery.The surgical outcome was successful with no reported adverse effects to the patient.

• Brand Name: VSP SYSTEM
• Type of Device: 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 ; 7206431055
• MDR Report Key: 12763649
• MDR Text Key: 282007343
• Report Number: 1724955-2021-00004
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 00816847020794
• UDI-Public: (01)00816847020794(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: Fibula Cutting Guide
• Device Lot Number: 155303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male