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

Model Number	LeFort Marking Guide
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Tooth Fracture (2428)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: LEFORT MARKING GUIDE
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton, co
• MDR Report Key: 10396978
• Report Number: 1724955-2020-00002
• Device Sequence Number: 3529012
• Product Code: DZJ
• UDI-Device Identifier: 00816847020596
• UDI-Public: (01)00816847020596
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

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: LeFort Marking Guide
• Device Lot Number: 133326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/12/2020
• 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