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

Model Number	Final Surgical Splint
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Malunion of Bone (4529)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1724955-2023-00002
• Device Sequence Number: 5759230
• Product Code: DZJ
• UDI-Device Identifier: 00816847020541
• UDI-Public: (01)00816847020541(10),(01)00816847020534(10)
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K192192
• 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): 01/20/2023

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: Final Surgical Splint
• Device Catalogue Number: VSPO-302
• 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: 08/10/2022
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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: Other
• Patient Age: 21 YR
• Patient Sex: Female