MAUDE Adverse Event Report: 3D SYSTEMS VSP SYSTEMS; SURGICAL SPLINT

Model Number	VSPO-550
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A maxillofacial surgical procedure utilizing vsp systems products was canceled due to a reported surgical splint fit concern after incisions were made, preventing the surgeon from proceeding with osteotomies.Digital reviews were unable to replicate the reported fit issue.

• Brand Name: VSP SYSTEMS
• Common Device Name: SURGICAL SPLINT
• Manufacturer (Section D): 3D SYSTEMS; 5381 s alkire st.; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 s alkire st; littleton CO 80127
• Manufacturer Contact: david behrman ; 1113 york ave unit 14c; new york, NY 10065
• MDR Report Key: 22288138
• Report Number: 1724955-2025-00006
• Device Sequence Number: 15531247
• Product Code: DZJ
• UDI-Device Identifier: 00816847020510
• UDI-Public: (01)00816847020510(10)
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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 Model 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: 05/20/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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: 20 YR
• Patient Sex: Unknown