MAUDE Adverse Event Report: 3D SYSTEMS VSP SYSTEM; VSP RECONSTRUCTION

Model Number Fibula Cutting Guide with Implant Placement

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

The dental implant placement on the fibula cutting guide with implant placement was placed on the anterior surface instead of the posterior surface.The issue was identified prior to surgery and the implant placement feature on the guide was not used.The issue caused no harm to the patient and did not cause a delay in surgery.

Event Description

The dental implant placement on the fibula cutting guide with implant placement was placed on the anterior surface instead of the posterior surface.The issue was identified prior to surgery and the implant placement feature on the guide was not used.The issue caused no harm to the patient and did not cause a delay in surgery.

• Brand Name: VSP SYSTEM
• Type of Device: VSP RECONSTRUCTION
• 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: 10292304
• MDR Text Key: 199486854
• Report Number: 1724955-2020-00001
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 00816847020770
• UDI-Public: (01)00816847020770(10)134943
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Fibula Cutting Guide with Implant Placement
• Device Lot Number: 134943
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2020
• 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: 51 YR