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

Model Number	Mandible Cutting Guide
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation into the complaint showed the mandible cutting guide was properly designed to the virtual surgical plan.Upon further investigation, it was determined that the surgical plan was altered by 3d systems commercial partner and not communicated to 3d systems.The virtual plan was not updated to reflect the new osteotomy path.As a result, the prosthesis did not initially fit to the patient's anatomy. .
Event or Problem Description
While utilizing a vsp mandible cutting guide, the surgeon indicated the planned osteotomy did not match the osteotomy that a temporomandibular joint prosthesis was design to.The surgeon reported a 90 minute delay as a result of the discrepancy.

• Brand Name: VSP SYSTEMS
• Common Device Name: MANDIBLE CUTTING GUIDE
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 s. alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 s alkire circle; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 s alkire circle; littleton, CO 80127 ; 7206431011
• MDR Report Key: 16343801
• Report Number: 1724955-2023-00005
• Device Sequence Number: 6803986
• Product Code: DZJ
• UDI-Device Identifier: 00816847020817
• UDI-Public: (01)00816847020817(10)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2023

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 Model Number: Mandible Cutting Guide
• 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: 01/11/2023
• Initial Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2022
• 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: 6 YR
• Patient Sex: Female