MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEM; FINAL SURGICAL SPLINT

Model Number	Final Surgical Splint
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon further investigation from the surgeon and 3ds, it was determined that the final surgical splint was designed off an incorrect model of the patient's mandible.This complaint is being reported due to the surgical delay time of 1-2 hours.No adverse effects were reported after surgery.
Event or Problem Description
The vsp system final surgical splint did not fit the surgeon's planned final position of the patient's mandible during a vsp orthognathic tmj surgery.The surgical delay was reported to be 1-2 hours for achieving the splint to fit the patient's final occlusion.

• Brand Name: VSP SYSTEM
• Common Device Name: FINAL SURGICAL SPLINT
• 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: 13891031
• Report Number: 1724955-2022-00005
• Device Sequence Number: 1764501
• Product Code: DZJ
• UDI-Device Identifier: 00816847020541
• UDI-Public: (01)00816847020541(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
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

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: Final Surgical Splint
• Device Catalogue Number: VSPO-302
• Device Lot Number: 156423
• 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: 03/01/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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: 33 YR
• Patient Sex: Male