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

Model Number	Fibula Cutting Guide
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the design files for the fibula cutting guide found that the guides were designed correctly to the specifications and the surgical plan performed by the surgeon.
Event or Problem Description
During a reconstruction surgery featuring virtual surgical planning, the use of a fibula cutting guide led to a fibula segment which was reported to be too large for the mandible by approximately 5 mm.The surgeon manually cut the segment again to achieve proper fit and reported a 60-minute delay in the procedure.

• Brand Name: VSP SYSTEM
• Common Device Name: FIBULA CUTTING GUIDE
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 s alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 s alkire circle; litteton CO 80127
• Manufacturer Contact: ben johnson ; 5381 s alkire circle; littleton, CO 80127 ; 7206431011
• MDR Report Key: 15827763
• Report Number: 1724955-2022-00015
• Device Sequence Number: 6004610
• Product Code: DZJ
• UDI-Device Identifier: 00816847020794
• UDI-Public: (01)00816847020794(10)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2022

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 Model Number: Fibula Cutting Guide
• Device Catalogue Number: VSPR-400
• Device Lot Number: 174133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male