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

Model Number	Intermediate Surgical Splint
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After review of the patient's post operative scans, it was identified that the mandible is not in the correct planned final position and deviated to the left side.3ds performed an investigation that identified no issues with the product or process performed by 3d systems.This complaint is being reported due to a revision surgery scheduled for (b)(6) 2021.At this point, 3ds cannot confirm that our products did not cause or contribute to this planned revision surgery.
Event or Problem Description
It was reported that for a vsp/tmj combination case, the vsp system intermediate splint could have contributed to a deviated implant positioning for a bilateral joint revision surgery resulting in malpositioned tmj devices on the patient's left side.

• Brand Name: VSP SYSTEM
• Common Device Name: INTERMEDIATE SURGICAL SPLINT
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 south alkire circle; littleton, CO 80127 ; 7206431001
• MDR Report Key: 12763792
• Report Number: 1724955-2021-00005
• Device Sequence Number: 3343442
• Product Code: DZJ
• UDI-Device Identifier: 00816847020534
• UDI-Public: (01)00816847020534(10)127817
• 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): 10/21/2021

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: Health Professional
• Device Model Number: Intermediate Surgical Splint
• Device Catalogue Number: VSPO-302
• Device Lot Number: 127817
• 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: 10/13/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female