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

Catalog Number	VSP-205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a maxillofacial surgery involving the implantation of a custom inplant, the surgeon reported that the implant was not seating properly on the patient anatomy and the surgeon was unable to complete the procedure as planned.Vsp system surgical marking guides were provided by 3d systems to assist the surgeon in the procedure.

• Brand Name: VSP SYSTEM
• Common Device Name: MAXILLA MARKING GUIDE
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 s alkire st; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 s alkire st; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 s alkire st; littleton, CO 80127
• MDR Report Key: 22542824
• Report Number: 1724955-2025-00007
• Device Sequence Number: 20590368
• Product Code: DZJ
• UDI-Device Identifier: 00816847020848
• UDI-Public: (01)00816847020848(10)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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 Catalogue Number: VSP-205
• 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: 07/07/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• 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 Age: 65 YR
• Patient Sex: Male