MAUDE Adverse Event Report: 3D SYSTEMS VSP SYSTEM; LEFORT MARKING GUIDE

Model Number LeFort Marking Guide

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Tooth Fracture (2428)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

The surgeon indicated that the patient was in orthodontics requiring leverage using orthodontic wire and brackets to maintain the dental positioning.In this case, the orthodontic wire was cut after the intraoral scans had been taken on (b)(6) 2020 and prior to the surgery date.The surgeon indicated the observed tooth movement was likely to have occurred during this time causing a poor fit of the guides and splints.In light of this information and following the review of the correct preparation, planning, and design of this case, 3d systems has determined to not be at fault.

Event Description

Surgeon indicated that they were unable to fit the patient's left side anatomy into the 3d systems vsp system surgical splints, and that the 3d systems vsp system lefort marking guide guided their cut into the patient's cuspid tooth root.The surgeon informed 3d systems personnel that the injury was not serious and that only the dentin of the root had been nicked.The patient is healing well and the tooth root is expected to make a full recovery.Investigation indicated no 3d systems failure modes.

• Brand Name: VSP SYSTEM
• Type of Device: LEFORT MARKING GUIDE
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton, co
• Manufacturer (Section G): 3D SYSTEMS; 5381 south alkire circle; littleton, co
• Manufacturer Contact: scott brewer ; 5381 south alkire circle; littleton, co ; 6431001
• MDR Report Key: 10396978
• MDR Text Key: 202577140
• Report Number: 1724955-2020-00002
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 00816847020596
• UDI-Public: (01)00816847020596
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LeFort Marking Guide
• Device Lot Number: 133326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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