MAUDE Adverse Event Report: 3D SYSTEMS VSP SYSTEM; INTERMEDIATE SPLIT

Model Number	Intermediate Surgical Splint
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prior to the surgery, the surgeon notified 3d systems the intermediate surgical splint did not set the patient's occlusal anatomy into the correct intermediate occlusion.After a digital review investigation, it was determined the intermediate splints were designed using an stl that did not represent the surgeon's requested intermediate occlusion for the patient.3d systems relayed this to the surgeon, and the surgeon elected to alter the surgical plan to allow the intermediate splint to be used and achieve the same planned final occlusion.The surgeon reported the surgery to be successful and the issue resulted in no delay to the surgery.
Event or Problem Description
The surgeon reported the vsp system intermediate splint did not match the planned intermediate position for the patient's mandible for double jaw orthognathic surgery.

• Brand Name: VSP SYSTEM
• Common Device Name: INTERMEDIATE SPLIT
• Manufacturer (Section D): 3D SYSTEMS; 5381 south alkire circle; littleton CO 80127
• MDR Report Key: 11606111
• Report Number: 1724955-2021-00002
• Device Sequence Number: 3544592
• Product Code: DZJ
• UDI-Device Identifier: 00816847020534
• UDI-Public: (01)00816847020534(10)143006
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2021

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: No Information
• Device Model Number: Intermediate Surgical Splint
• Device Lot Number: 143006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 04/01/2021
• 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: 16 YR