MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEM; VSP RECONSTRUCTION

Model Number	Fibula Cutting Guide with Implant Placement
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	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
For a vsp reconstruction procedure, the surgeon identified an error documented in the 3d systems case report.The plan b vsp reconstruction surgical plan documented the plan a fibula guide in one of the images.
Additional Manufacturer Narrative
This issue was identified by the surgeon during surgery, but did not contribute to any significant surgical delay.3d systems verified that the manufactured hybrid fibula cutting guides for both plan a and plan b were designed to the correct surgical plans, respectively; 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 during surgery.The surgical outcome was successful with no reported adverse effects to the patient.
Event or Problem Description
For a vsp reconstruction procedure, the surgeon identified an error documented in the 3d systems case report.The plan b vsp reconstruction surgical plan documented the plan a fibula guide in one of the images.
Additional Manufacturer Narrative
This issue was identified by the surgeon during surgery, but did not contribute to any significant surgical delay.3d systems verified that the manufactured hybrid fibula cutting guides for both plan a and plan b were designed to the correct surgical plans, respectively; 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 during surgery.The surgical outcome was successful with no reported adverse effects to the patient.

• Brand Name: VSP SYSTEM
• Common Device Name: VSP RECONSTRUCTION
• 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: 12849857
• Report Number: 1724955-2021-00007
• Device Sequence Number: 11835360
• Product Code: DZJ
• UDI-Device Identifier: 00816847020770
• UDI-Public: (01)00816847020770(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): 11/19/2021

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
• Operator of Device: Health Professional
• Device Model Number: Fibula Cutting Guide with Implant Placement
• Device Catalogue Number: VSPR-507
• Device Lot Number: 156353
• 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: 11/01/2021
• Initial Report FDA Received Date: 11/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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: 38 YR
• Patient Sex: Female