VSP System LeFort Marking GuideRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816847020596), received between Aug 12, 2020 and Nov 25, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A MAXILLOFACIAL PROCEDURE INVOLVING VSP SYSTEMS DEVICES, THE SURGEON REPORTED DRILLING ADDITIONAL HOLES IN THE PATIENT ANATOMY IN ORDER TO FIT A CUSTOM PLATE AND ACHIEVE THE DESIRED DENTAL OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23651664 ↗
• InjuryMar 15, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  DURING MAXILLOFACIAL SURGERY, THE SURGEON HAD AN ISSUE FITTING A CUSTOMIZED RECONSTRUCTION PLATE TO THE MEDIAL ASPECT OF THE MIDFACE OF THE PATIENT. THEY HAD AN ISSUE FULLY SEATING THE LEFORT MARKING GUIDE ON THE PATIENT'S RIGHT SIDE. THE MEDIAL HOLES FOR THE PLATE ON THE PATIENT'S RIGHT MIDFACE DID NOT ALIGN WITH THE HOLES MARKED BY THE GUIDE. THIS REQUIRED THE SURGEON TO DRILL ADDITIONAL HOLES IN THE PATIENT'S ANATOMY IN ORDER TO FIT THE CUSTOMIZED PLATE. THE SURGERY WAS SUCCESSFUL WITH NO OBSERVABLE CLINICAL SYMPTOMS REPORTED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549456 ↗
• InjuryAug 12, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  SURGEON INDICATED THAT THEY WERE UNABLE TO FIT THE PATIENT'S LEFT SIDE ANATOMY INTO THE 3D SYSTEMS VSP SYSTEM SURGICAL SPLINTS, AND THAT THE 3D SYSTEMS VSP SYSTEM LEFORT MARKING GUIDE GUIDED THEIR CUT INTO THE PATIENT'S CUSPID TOOTH ROOT. THE SURGEON INFORMED 3D SYSTEMS PERSONNEL THAT THE INJURY WAS NOT SERIOUS AND THAT ONLY THE DENTIN OF THE ROOT HAD BEEN NICKED. THE PATIENT IS HEALING WELL AND THE TOOTH ROOT IS EXPECTED TO MAKE A FULL RECOVERY. INVESTIGATION INDICATED NO 3D SYSTEMS FAILURE MODES.

  Patient problems: Tooth Fracture

  MAUDE report 10396978 ↗

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