MAUDE Adverse Event Report: 3D SYSTEMS HEALTHCARE VSP SYSTEMS; MANDIBLE CUTTING GUIDE

Catalog Number	VSPO-450
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Following a maxillofacial procedure utilizing vsp systems products, it was reported that the surgeon was unhappy with the surgical outcome and intends to perform a revision surgery.In particular, the surgeon noted difficulty utilizing the provided mandible cutting guides.

• Brand Name: VSP SYSTEMS
• Common Device Name: MANDIBLE CUTTING GUIDE
• Manufacturer (Section D): 3D SYSTEMS HEALTHCARE; 5381 s alkire st; littleton CO 80127
• Manufacturer (Section G): 3D SYSTEMS HEALTHCARE; 5381 s alkire st; littleton CO 80127
• Manufacturer Contact: ben johnson ; 5381 s alkire st; littleton, CO 80127 ; 7206431011
• MDR Report Key: 19559935
• Report Number: 1724955-2024-00006
• Device Sequence Number: 20534518
• Product Code: DZJ
• UDI-Device Identifier: 00816847020824
• UDI-Public: (01)00816847020824(10)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/03/2024

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
• Device Catalogue Number: VSPO-450
• 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: 05/21/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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: 33 YR
• Patient Sex: Unknown