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

Catalog Number	VSPR-500
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 1724955-2023-00013
• Device Sequence Number: 20705552
• Product Code: DZJ
• UDI-Device Identifier: 00816847020770
• UDI-Public: (01)00816847020770(10)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VSPR-500
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Prefer Not To Disclose