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

Model Number	Mandible Marking Guide
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During a vsp orthognathics and tmj surgery, there were issues with the fit of the mandibular prosthesis.The surgeon drilled the predictive holes indicated by the mandible marking guide and later found that the mandibular prosthesis would not meet the fossa once it was screwed into the mandible.As a result, the surgeon did not use the pre-drilled holes and preferred a different positioning of the mandible prosthesis.
Additional Manufacturer Narrative
This issue was identified by the surgeon intraoperatively.3d systems performed a review of the digital design files and overlayed the planned data with the patient post-operative data provided by the surgeon.It was found that the mandible marking guide fit the patients anatomy and lined up with the predictive holes.The surgeon reported that they had to reposition the mandibular component to meet the fossa, which resulted in additional holes on the patient's mandible.Surgery was successful and no adverse events to the patient were reported after surgery.

• Brand Name: VSP SYSTEM
• Common Device Name: MANDIBLE MARKING GUIDE
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 s alkire street; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 s alkire street; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 s alkire street; littleton, CO 80127 ; 7206431001
• MDR Report Key: 14881088
• Report Number: 1724955-2022-00007
• Device Sequence Number: 12315996
• Product Code: DZJ
• UDI-Device Identifier: 00816847020824
• UDI-Public: (01)00816847020824(10)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K210347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2022

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 Marking Guide
• Device Catalogue Number: VSPO-312
• Device Lot Number: 160771
• 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: 06/01/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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: 62 YR
• Patient Sex: Female