MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEMS; MAXILLA CUTTING GUIDE

Model Number	LeFort Marking Guide
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During maxillofacial surgery, the surgeon had an issue fitting a customized reconstruction plate to the medial aspect of the midface of the patient.They had an issue fully seating the lefort marking guide on the patient's right side.The medial holes for the plate on the patient's right midface did not align with the holes marked by the guide.This required the surgeon to drill additional holes in the patient's anatomy in order to fit the customized plate.The surgery was successful with no observable clinical symptoms reported by the surgeon.

• Brand Name: VSP SYSTEMS
• Common Device Name: MAXILLA CUTTING GUIDE
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 south alkire circle; littleton, CO 80127 ; 7206431011
• MDR Report Key: 16549456
• Report Number: 1724955-2023-00008
• Device Sequence Number: 6043155
• Product Code: DZJ
• UDI-Device Identifier: 00816847020596
• UDI-Public: (01)00816847020596(10)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/10/2023

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 Catalogue Number: VSPO-550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown