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

Model Number	Intermediate Surgical Splint
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	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A medical professional reported that during a surgical procedure, it was discovered that one of the devices provided by 3d systems had not been properly labeled for the planned procedure which resulted in the device not being used.The label for the device in question did not match the plan present in the case report as it was labeled for a maxilla first surgery while the case was planned to be a mandible first procedure.No patient harm was reported and the surgeon reported no delay.

• Brand Name: VSP SYSTEMS
• Common Device Name: INTERMEDIATE SURGICAL SPLINT
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 s alkire circle; littleton 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 ; 7206431001
• MDR Report Key: 17326317
• Report Number: 1724955-2023-00012
• Device Sequence Number: 14833647
• Product Code: DZJ
• UDI-Device Identifier: 00816847020534
• UDI-Public: (01)00816847020534(10)
• Combination Product (Y/N): N
• 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): 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Intermediate Surgical Splint
• Device Catalogue Number: VSPO-302, 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: 06/14/2023
• Initial Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown