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

Catalog Number	VSPO-302
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon reported that following a procedure that utilized vsp system, the patient specific prosthesis did not end up in the proper position post-surgery.The patient reported discomfort which led to a revision surgery.

• Brand Name: VSP SYSTEM
• Common Device Name: INTERMEDIATE SURGICAL SPLINT
• 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 ; 7206431011
• MDR Report Key: 21231338
• Report Number: 1724955-2025-00004
• Device Sequence Number: 12912268
• Product Code: ELS
• UDI-Device Identifier: 00816847020534
• UDI-Public: (01)00816847020534(10)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/14/2025

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: VSPO-302
• 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: 01/02/2025
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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: 28 YR
• Patient Sex: Unknown