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

Model Number Final Surgical Splint

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 07/16/2020

Event Type  Injury  

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 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
• Type of Device: FINAL SURGICAL SPLINT
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton, co
• Manufacturer (Section G): 3D SYSTEMS; 5381 south alkire circle; littleton, co
• Manufacturer Contact: scott brewer ; 5381 south alkire circle; littleton, co ; 6431001
• MDR Report Key: 10396979
• MDR Text Key: 202580229
• Report Number: 1724955-2020-00003
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 00816847020541
• UDI-Public: (01)00816847020541(10)130178
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• 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 Lot Number: 130178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/09/2020
• 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: 48 YR