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

Model Number Intermediate Surgical Splint

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 05/29/2019

Event Type  Injury  

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 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
• Type of Device: VSP ORTHOGNATHICS
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• Manufacturer Contact: scott brewer ; 5381 south alkire circle; littleton, CO 80127 ; 7206431001
• MDR Report Key: 8724030
• MDR Text Key: 148926353
• Report Number: 1724955-2019-00001
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 00816847020534
• UDI-Public: (01)00816847020534(10)120559
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Intermediate Surgical Splint
• Device Lot Number: 120559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR