MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEMS; SURGICAL SPLINT

Model Number	Final Surgical Splint
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient had previously undergone lefort surgery and existing metal hardware was present in the preoperative scan.The metallic objects created scan artifact in the area the guides and plates would be placed, which was likely a contributing factor to the reported fit of the lefort drilling guide.
Event or Problem Description
While performing corrective jaw surgery utilizing vsp systems' lefort drilling guide and surgical splints, the surgeon reported the lefort drilling guide and surgical splint did not fit as anticipated.Additionally, the surgeon reported that the splints needed to be altered in the operating room to achieve a satisfactory fit.These issues contributed to a surgical delay of 120+ minutes.

• Brand Name: VSP SYSTEMS
• Common Device Name: SURGICAL SPLINT
• 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: 16391090
• Report Number: 1724955-2023-00006
• Device Sequence Number: 5138517
• Product Code: DZJ
• UDI-Device Identifier: 00816847020541
• UDI-Public: (01)00816847020541(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): 02/03/2023

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: Final Surgical Splint
• Device Catalogue Number: VSPO-302, VSP-550
• Device Lot Number: 179885
• 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: 01/18/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 21 YR
• Patient Sex: Male