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

Model Number Intermediate Surgical Splint

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 319292296
• Report Number: 1724955-2023-00012
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 00816847020534
• UDI-Public: (01)00816847020534(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR