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

Model Number Final Surgical Splint

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Malunion of Bone (4529)

Event Date 08/08/2022

Event Type  Injury  

Event Description

During an orthognathic surgical procedure, the surgeon had difficulty using the intermediate and final surgical splint to set the patient's final occlusion.This resulted in a revision surgery that took place on (b)(6) 2022 so the surgeon could fix the patient's occlusion.

Manufacturer Narrative

After internal review of the intermediate and final surgical splints, it was found that both parts were designed and manufactured properly to the patient's anatomy.Post-operative scans were requested to perform further investigation; however, these were never provided.No adverse events to the patient were reported after revision surgery.

• Brand Name: VSP SYSTEM
• Type of Device: INTERMEDIATE SURGICAL SPLINT, FINAL SURGICAL SPLINT
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 s alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 s alkire circle; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 s alkire circle; littleton, CO 80127 ; 7206431001
• MDR Report Key: 16380910
• MDR Text Key: 309599070
• Report Number: 1724955-2023-00002
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 00816847020541
• UDI-Public: (01)00816847020541(10),(01)00816847020534(10)
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K192192
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Final Surgical Splint
• Device Catalogue Number: VSPO-302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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: 21 YR
• Patient Sex: Female