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

Model Number Sagittal Split Marking Guide

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/19/2020

Event Type  Injury  

Event Description

Stryker facial id plating system (k193143) customized plates did not align with 3d systems guides (lefort marking guide, maxilla cutting guide, and sagittal split marking guide).This issue was identified during surgery after the surgeon had used the guides to fixate custom plates in the patient's maxilla and mandible.Upon identification, the plates were removed and new holes were drilled for fixation.The issue caused unnecessary holes to be drilled into the patient , however, the surgery was successful with no adverse effects to the patient.The issue added 90 additional minutes to the procedure.Investigation identified case planning files were incorrectly exported by 3d systems personnel resulting in the 3d systems guides to incorrectly indicate the custom plate fixation hole location for the surgical procedure.

• Brand Name: VSP SYSTEM
• Type of Device: SURGICAL GUIDE
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• Manufacturer Contact: scott brewer ; 5381 south alkire circle; littleton, CO 80127 ; 7206431001
• MDR Report Key: 11037135
• MDR Text Key: 222336430
• Report Number: 1724955-2020-00006
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 00816847020633
• UDI-Public: (01)00816847020633(10)141324
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Sagittal Split Marking Guide
• Device Lot Number: 141324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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: 19 YR