MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEMS; FIBULA CUTTING GUIDE

Catalog Number VSPR-500

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 08/22/2023

Event Type  Injury  

Event Description

During the process of a mandible reconstructive surgery, a fibula cutting guide was utilized which resulted in dental implant holes that did not properly align to the planned surgical positions.As a result, the dental implant holes were not used and a revision surgery was scheduled to correct the placement of the dental implant holes.A review of the guide found that all requirements were met and no defects were found in the design or manufacturing of the guide.

• Brand Name: VSP SYSTEMS
• Type of Device: FIBULA CUTTING GUIDE
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 s alkire st; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 s alkire st; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 s alkire st; littleton, CO 80127 ; 7206431011
• MDR Report Key: 17790071
• MDR Text Key: 323946273
• Report Number: 1724955-2023-00013
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VSPR-500
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• 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; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Prefer Not To Disclose