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

Model Number	Maxilla Cutting Guide
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
While performing surgery to place a temporomandibular joint prostheses, the surgeon reported that predictive holes that were predrilled utilizing a 3d systems maxilla cutting guide did not properly position a fossa prothesis.The surgeon needed to remove the prothesis along with the screws fixating it and adjust the position of the fossa prosthesis as a result.The surgeon reported the guide did not adequately engage the patient's anatomy to register the guide in the anterior/posterior directions.

• Brand Name: VSP SYSTEMS
• Common Device Name: MAXILLA 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; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 s alkire circle; littleton, CO 80127 ; 7206431011
• MDR Report Key: 16436720
• Report Number: 1724955-2023-00007
• Device Sequence Number: 3150641
• Product Code: DZJ
• UDI-Device Identifier: 00816847020831
• UDI-Public: (01)00816847020831(10)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

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 Model Number: Maxilla Cutting Guide
• Device Catalogue Number: VSPO-550
• 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: 01/25/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 10 YR
• Patient Sex: Male