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

Model Number	Mandible Cutting Guide
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During a vsp orthognathic single-jaw procedure, the surgeon had to manipulate the custom plates to achieve the correct occlusion.The surgical delay was reported to be 60 minutes or less.
Additional Manufacturer Narrative
The 3ds investigation is on-going and no issues have been identified thus far regarding the product manufactured, and processes performed by 3d systems.This complaint is being reported due to the surgical delay time of approximately 60 minutes.Post-operative data has been requested from the surgeon for further investigation.At this point, 3ds cannot confirm that our products did not cause or contribute to the poor fitment of the stryker custom plates resulting in an extensive surgical delay.

• Brand Name: VSP SYSTEM
• Common Device Name: MANDIBLE CUTTING GUIDE
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 south alkire circle; littleton, CO 80127 ; 7206431001
• MDR Report Key: 13695983
• Report Number: 1724955-2022-00004
• Device Sequence Number: 11213748
• 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: K120956
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/28/2022

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 Cutting Guide
• Device Catalogue Number: VSPO-302
• Device Lot Number: 161644
• 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: 02/16/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2021
• 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: 23 YR
• Patient Sex: Female