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

Model Number	Genioplasty Marking Guide
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: GENIOPLASTY MARKING GUIDE
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• MDR Report Key: 11135470
• Report Number: 1724955-2021-00001
• Device Sequence Number: 688872
• Product Code: DZJ
• UDI-Device Identifier: 00816847020671
• UDI-Public: (01)00816847020671(10)141285
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K192192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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: Genioplasty Marking Guide
• Device Lot Number: 141285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/07/2021
• 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: 22 YR