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

Model Number	Final Surgical Splint
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgeon believed that during a secondary review of the patient with 3d systems, the patient's occlusion was adjusted in an attempt to close the occlusion.3d systems has no record of a secondary review or a change in the surgical plan.The occlusion was set based on dental models and an occlusal bite indications that was received from the surgeon.The surgical splints corresponded to the specification and occlusion depicted within the vsp case report provided to the surgeon.The surgeon intends to place orthodontics to close the patient's bite after the implantation of the tmj devices.
Event or Problem Description
During a combination case involving virtual surgical planning (vsp) and stryker tmj-concepts, the surgeon reported a malocclusion after placement of the final surgical splint.The surgeon reported a 90-minute delay in surgery as they attempted to adjust the patient's occlusion intraoperatively.

• Brand Name: VSP SYSTEM
• Common Device Name: FINAL SURGICAL SPLINT
• 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: 15826424
• Report Number: 1724955-2022-00016
• Device Sequence Number: 6143164
• 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: 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): 11/14/2022

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: 160377
• 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: Not provided
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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: 40 YR
• Patient Sex: Female