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

Catalog Number	VSPO-550
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure utilizing vsp systems products, it was discovered that the surgical guide was not designed to properly follow the surgical plan, resulting in an osteotomy incompatible with the intended implant.This has necessitated the planning of a revision surgery to complete the implantation.

• Brand Name: VSP SYSTEMS
• Common Device Name: MAXILLA 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: ben johnson ; 5381 s alkire st; littleton, CO 80127 ; 7206431011
• MDR Report Key: 18914128
• Report Number: 1724955-2024-00002
• Device Sequence Number: 6971388
• Product Code: DZJ
• UDI-Device Identifier: 00816847020831
• UDI-Public: (01)00816847020831(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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2024

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?: Yes
• 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: 02/15/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Unknown