MAUDE Adverse Event Report: 3D SYSTEMS VSP SYSTEM; VSP ORTHOGNATHICS

Model Number	Intermediate Surgical Splint
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prior to surgery, the surgeon notified 3d systems the intermediate surgical splint did not set the patient's occlusal anatomy into the correct intermediate occlusion.This was discovered during a fit check performed by the surgeon on the patient.After a digital review investigation, it was determined that the intermediate splints were designed using an incorrect stl that did not represent the surgeon's requested intermediate occlusion for the patient.Upon notification, 3d systems recommended the surgeon not use the splint.The issue was then corrected and a new intermediate surgical splint was designed, manufactured, and shipped to the surgeon.The surgery was reported to be successful.
Event or Problem Description
The surgeon reported the intermediate surgical splint did not match the surgeon's planned intermediate position of the patient's maxilla for the maxillary/mandible orthognathic surgery.

• Brand Name: VSP SYSTEM
• Common Device Name: VSP ORTHOGNATHICS
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• MDR Report Key: 8724030
• Report Number: 1724955-2019-00001
• Device Sequence Number: 11393610
• Product Code: DZJ
• UDI-Device Identifier: 00816847020534
• UDI-Public: (01)00816847020534(10)120559
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K133907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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: Intermediate Surgical Splint
• Device Lot Number: 120559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR