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

Catalog Number	VSPO-550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a maxillofacial procedure in which vsp systems devices were utilized, the patient's mandible dislocated and the surgeon plans to do a revision surgery.

• Brand Name: VSP SYSTEMS
• Common Device Name: MANDIBLE 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: 19506621
• Report Number: 1724955-2024-00005
• Device Sequence Number: 19684273
• Product Code: DZJ
• UDI-Device Identifier: 00816847020817
• UDI-Public: (01)00816847020817(10)
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2024

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?: No
• Device Catalogue Number: VSPO-550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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: 74 YR
• Patient Sex: Unknown