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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During surgery, mandible guides with php were used mark the predictive holes and to place the mandibular component of the prothesis.When placed onto the drilled holes, the custom mandibular component of the prothesis was interfering with the posterior fossa component, causing the intermediate splint to not fit appropriately.This led to the surgeon having to drill new holes for the mandibular component and replacing it in a spot where it would not interfere with the fossa component.Surgeon said the guides fit fine.A post op study will be done to determine where the predictive holes were drilled compared to the guided position.

• 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 80127
• Manufacturer Contact: michael bozeman ; 5381 s. alkire st.; littleton, CO 80127
• MDR Report Key: 25586206
• Report Number: 1724955-2026-00004
• Device Sequence Number: 14890974
• Product Code: DZJ
• UDI-Device Identifier: 00816847020817
• UDI-Public: (01)00816847020817(10)241076
• 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): 06/22/2026

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: 02/24/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2026
• 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 Age: 67 YR
• Patient Sex: Female