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

Model Number	Fibula Cutting Guide
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• 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 ; 7206431055
• MDR Report Key: 12763649
• Report Number: 1724955-2021-00004
• Device Sequence Number: 11911055
• Product Code: DZJ
• UDI-Device Identifier: 00816847020794
• UDI-Public: (01)00816847020794(10)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K120956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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
• Device Model Number: Fibula Cutting Guide
• Device Lot Number: 155303
• 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: 09/01/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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: 58 YR
• Patient Sex: Male