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

Model Number	Final Surgical Splint
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the surgery, the surgeon identified that the vsp system final surgical splint and vsp system final palatal insert were too narrow to be designed off the final occlusion digitally planned during the virtual surgical planning session.The surgeon opted to not use the splints on the patient and instead created his own surgical splints as a substitute, resulting in a temporary delay in surgery.After a digital review investigation, it was determined that the final splints were designed using an incorrect stl that did not represent the surgeon's requested final occlusion for the patient.
Event or Problem Description
The surgeon reported the vsp system final surgical splint and final palatal splint did not match the surgeon's planned final position of the patient's maxilla for the maxillary/condylectomy orthognathic surgery.

• Brand Name: VSP SYSTEM
• Common Device Name: FINAL SURGICAL SPLINT
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton, co
• MDR Report Key: 10396979
• Report Number: 1724955-2020-00003
• Device Sequence Number: 3529011
• Product Code: DZJ
• UDI-Device Identifier: 00816847020541
• UDI-Public: (01)00816847020541(10)130178
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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 Lot Number: 130178
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/12/2020
• 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: 48 YR