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

Catalog Number	VSPO-450
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	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a maxillofacial surgery, it was reported that the surgeon had difficulty fitting a mandible prosthesis to the patient using a 3d systems mandible marking guide, which caused a delay in the operation of approximately 4 hours.The procedure was completed without additional patient harm.

• Brand Name: VSP SYSTEMS
• Common Device Name: MANDIBLE MARKING 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: 19175138
• Report Number: 1724955-2024-00003
• Device Sequence Number: 7330893
• Product Code: DZJ
• UDI-Device Identifier: 00816847020824
• UDI-Public: (01)00816847020824(10)
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: VSPO-450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2023
• 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: 29 YR
• Patient Sex: Unknown