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

Model Number	Mandible Cutting Guide
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
While performing surgery to place temporomandibular joint prostheses, the surgeon reported that predictive holes that were predrilled utilizing a 3d systems mandible cutting guide did not properly align to the prothesis.
Additional Manufacturer Narrative
A review of the mandible cutting guides found that the predictive holes present on the cutting guide did properly indicate the locations of the necessary drill holes based on the inputs provided to 3d systems.A definitive cause for the surgeon's experience could not be identified.

• 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: 16330214
• Report Number: 1724955-2023-00004
• Device Sequence Number: 12466840
• Product Code: DZJ
• UDI-Device Identifier: 00816847020817
• UDI-Public: (01)00816847020817(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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2023

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?: No
• 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: 01/10/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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: 35 YR
• Patient Sex: Female