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

Model Number Genioplasty Marking Guide

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/04/2020

Event Type  Injury  

Event Description

An unintended hole was drilled in to the patient's mandibular body during the utilization of 3d systems polyamide genioplasty marking guide in surgery.The additional hole was identified after the fixation of custom plates.A discrepancy between the genioplasty marking guide provided to the surgeon and the guide represented in the case report was identified during the investigation.The design of the genioplasty marking guide was revised in process (removal of two (2) marking holes for custom plate fixation) and the case report was not properly updated to document the design revision.A titanium alloy genioplasty marking guide, for use to interface with surgical cutting and drilling tools, was provided with the case.Guidance for use of polyamide and titanium guides was provided in the operative technique section of the case report.The surgical outcome was successful with no adverse affect to the patient.

• Brand Name: VSP SYSTEM
• Type of Device: GENIOPLASTY MARKING GUIDE
• 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: 11135470
• MDR Text Key: 227006440
• Report Number: 1724955-2021-00001
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 00816847020671
• UDI-Public: (01)00816847020671(10)141285
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Genioplasty Marking Guide
• Device Lot Number: 141285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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: 22 YR