MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEMS; FINAL SURGICAL SPLINT, LEFORT DRILLING GUIDE LEFT/RIGHT

Catalog Number VSPO-550/302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2022

Event Type  Injury  

Event Description

While utilizing 3d systems' final splint and lefort drilling guides, the surgeon had difficulties creating the anticipated postoperative occlusion as represented in the virtual surgical plan, resulting in a 2-hour delay in surgery.

Manufacturer Narrative

The surgeon indicated the devices properly fit the patient at the time of surgery."a internal review" of the final splints and lefort drilling guides showed they were properly manufactured to the specification represented in the virtual surgical plan.

• Brand Name: VSP SYSTEMS
• Type of Device: FINAL SURGICAL SPLINT, LEFORT DRILLING GUIDE LEFT/RIGHT
• 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 ; 7206431011
• MDR Report Key: 16219180
• MDR Text Key: 307878792
• Report Number: 1724955-2023-00001
• Device Sequence Number: 1
• Product Code: DZJ
• Combination Product (y/n): N
• 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: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VSPO-550/302
• Device Lot Number: 178386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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: Male