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

Model Number	Fibula Cutting Guide with Implant Placement
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dental implant placement on the fibula cutting guide with implant placement was placed on the anterior surface instead of the posterior surface.The guide was used to mark dental implant holes prior to drilling of the holes, then subsequent placement.The error was identified upon placement of fibula segments in the patient's face.The dental implants were removed upon identification and holes were subsequently bone grafted.At time of this writeup the surgeon plans to place dental implants in a second procedure (as is the standard in fibula graft procedures without the usage of vsp for dental implant placement).The patient condition was reported to be acceptable after surgery and the oral surgeon estimated a 2-3 hour delay to surgery to address the misplaced implants.
Event or Problem Description
The dental implant placement on the fibula cutting guide with implant placement was placed on the anterior surface instead of the posterior surface.

• Brand Name: VSP SYSTEM
• Common Device Name: VSP RECONSTRUCTION
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• MDR Report Key: 9293209
• Report Number: 1724955-2019-00002
• Device Sequence Number: 13953969
• Product Code: DZJ
• UDI-Device Identifier: 00816847020770
• UDI-Public: (01)00816847020770(01)127258
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

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 Lot Number: 127258
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/07/2019
• 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: Other
• Patient Age: 17 YR