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

Model Number Fibula Cutting Guide with Implant Placement

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 10/17/2019

Event Type  Injury  

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 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
• Type of Device: VSP RECONSTRUCTION
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• Manufacturer Contact: scott brewer ; 5381 south alkire circle; littleton, CO 80127 ; 7206431001
• MDR Report Key: 9293209
• MDR Text Key: 165577451
• Report Number: 1724955-2019-00002
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 00816847020770
• UDI-Public: (01)00816847020770(01)127258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Fibula Cutting Guide with Implant Placement
• Device Lot Number: 127258
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2019
• 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: 17 YR