MAUDE Adverse Event Report: 3D SYSTEMS VSP SYSTEM; INTERMEDIATE SPLINT

Model Number Intermediate Surgical Splint

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

The sales representative notified 3d systems after patient surgery that the intermediate surgical splint did not set the patient's occlusal anatomy into the correct intermediate occlusion.The surgeon was able to adjust accordingly to achieve the correct final occlusion during surgery; however, contacted 3ds with concerns of why there was such a large deviation present.3ds performed an investigation that digitally reviewed the virtual surgical planning and design files.It was determined the intermediate splints were designed off of stl files that did not represent the surgeon's requested intermediate occlusion for the patient.This information was provided to the surgeon.No adverse effects were reported after surgery.

Event Description

The surgeon reported the vsp system intermediate splint did not match the planned intermediate position for the patient's maxilla for double jaw orthognathic surgery.

• Brand Name: VSP SYSTEM
• Type of Device: INTERMEDIATE SPLINT
• 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: ben johnson ; 5381 south alkire circle; littleton, CO 80127 ; 7206431055
• MDR Report Key: 12197386
• MDR Text Key: 262478465
• Report Number: 1724955-2021-00003
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 00816847020534
• UDI-Public: (01)00816847020534(10)152068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: Intermediate Surgical Splint
• Device Lot Number: 152068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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: 25 YR