VSP System Maxilla Marking GuideRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816847020848), received between Jul 18, 2025 and Jul 18, 2025 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K120956, K133907, K192192); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A MAXILLOFACIAL SURGERY INVOLVING THE IMPLANTATION OF A CUSTOM INPLANT, THE SURGEON REPORTED THAT THE IMPLANT WAS NOT SEATING PROPERLY ON THE PATIENT ANATOMY AND THE SURGEON WAS UNABLE TO COMPLETE THE PROCEDURE AS PLANNED. VSP SYSTEM SURGICAL MARKING GUIDES WERE PROVIDED BY 3D SYSTEMS TO ASSIST THE SURGEON IN THE PROCEDURE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22542824 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120956, K133907, K192192. One submission often covers many models, so check the product and lot details in each record.

• Z-1510-2022 · May 17, 2022 · Open, Classified
  3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile