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

Model Number	Intermediate Surgical Splint
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTERMEDIATE SPLINT
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• MDR Report Key: 12197386
• Report Number: 1724955-2021-00003
• Device Sequence Number: 11093531
• Product Code: DZJ
• UDI-Device Identifier: 00816847020534
• UDI-Public: (01)00816847020534(10)152068
• 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): 07/12/2021

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: No Information
• Device Model Number: Intermediate Surgical Splint
• Device Lot Number: 152068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/20/2021
• 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: 25 YR