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

Catalog Number	VSPO-550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
While performing the vertical osteotomy of the bsso, the resident assumed the cutting slot ended at the inferior border and continued cutting based off that.Confusion also arose when looking at the nerve to distal mandible measurements in the case report as the resident believed there should've been two measurements - one at the anterior cut of the wedge and another at the posterior.These combined resulted in the patients nerves being severed bilaterally.

• Brand Name: VSP SYSTEM
• Common Device Name: CUTTING 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 80137
• Manufacturer Contact: ben johnson ; 5381 s alkire st; littleton, CO 80127
• MDR Report Key: 24617726
• Report Number: 1724955-2026-00003
• Device Sequence Number: 15997833
• Product Code: DZJ
• UDI-Device Identifier: 00816847020824
• UDI-Public: 00816847020824
• Combination Product (Y/N): N
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: 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: 02/19/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2026
• 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