MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEM; VSP ORTHOGNATHICS

Model Number	Surgical Splint
Medical Device Problem Codes	Device-Device Incompatibility (2919); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This issue was identified by the surgeon intraoperatively, but did not contribute to any significant surgical delay.3d systems performed a review of the digital design files.It was found that a small portion of the initial surgical splint extended out and did not allow a flush fit at the connection point with the titanium guide.However, the connection between the initial splint and maxilla cutting guide was secure; and passed fit check during final inspection.3d systems communicated these findings to the surgeon.Although the surgical outcome was successful, the surgeon reported that the maxilla required replating, which resulted in additional holes on the patient's midface.
Event or Problem Description
For a vsp orthognathic procedure, the surgeon was not able achieve a flush fit at the connecting point between two hybrid vsp 2.0 guides (nylon initial surgical splint and titanium right maxilla cutting guide).As a result, the surgeon had to replate the patient's maxilla.

• Brand Name: VSP SYSTEM
• Common Device Name: VSP ORTHOGNATHICS
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 south alkire circle; littleton, CO 80127
• MDR Report Key: 13236689
• Report Number: 1724955-2022-00001
• Device Sequence Number: 11844752
• Product Code: DZJ
• UDI-Device Identifier: 00816847020510
• UDI-Public: (01)00816847020510(10);(01)00816847020831(10)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2022

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: Surgical Splint
• Device Catalogue Number: VSPO-302; VSPO-550
• Device Lot Number: 160399
• 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: 12/16/2021
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2021
• 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: 19 YR
• Patient Sex: Male