Skip to content

VSP System Sagittal Split Marking GuideRecalls & reported problems

3d Systems, Inc. · A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816847020633), received between Dec 18, 2020 and Dec 18, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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

Device problems

  • Manufacturing, Packaging or Shipping Problem1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

  • InjuryDec 18, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    STRYKER FACIAL ID PLATING SYSTEM (K193143) CUSTOMIZED PLATES DID NOT ALIGN WITH 3D SYSTEMS GUIDES (LEFORT MARKING GUIDE, MAXILLA CUTTING GUIDE, AND SAGITTAL SPLIT MARKING GUIDE). THIS ISSUE WAS IDENTIFIED DURING SURGERY AFTER THE SURGEON HAD USED THE GUIDES TO FIXATE CUSTOM PLATES IN THE PATIENT'S MAXILLA AND MANDIBLE. UPON IDENTIFICATION, THE PLATES WERE REMOVED AND NEW HOLES WERE DRILLED FOR FIXATION. THE ISSUE CAUSED UNNECESSARY HOLES TO BE DRILLED INTO THE PATIENT , HOWEVER, THE SURGERY WAS SUCCESSFUL WITH NO ADVERSE EFFECTS TO THE PATIENT. THE ISSUE ADDED 90 ADDITIONAL MINUTES TO THE PROCEDURE. INVESTIGATION IDENTIFIED CASE PLANNING FILES WERE INCORRECTLY EXPORTED BY 3D SYSTEMS PERSONNEL RESULTING IN THE 3D SYSTEMS GUIDES TO INCORRECTLY INDICATE THE CUSTOM PLATE FIXATION HOLE LOCATION FOR THE SURGICAL PROCEDURE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 11037135 ↗

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

Other Driver, Wire, And Bone Drill, Manual devices

All Driver, Wire, And Bone Drill, Manual devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.