VSP System Genioplasty Marking GuideRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816847020671), received between Jan 7, 2021 and Jan 7, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJan 7, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  AN UNINTENDED HOLE WAS DRILLED IN TO THE PATIENT'S MANDIBULAR BODY DURING THE UTILIZATION OF 3D SYSTEMS POLYAMIDE GENIOPLASTY MARKING GUIDE IN SURGERY. THE ADDITIONAL HOLE WAS IDENTIFIED AFTER THE FIXATION OF CUSTOM PLATES.. A DISCREPANCY BETWEEN THE GENIOPLASTY MARKING GUIDE PROVIDED TO THE SURGEON AND THE GUIDE REPRESENTED IN THE CASE REPORT WAS IDENTIFIED DURING THE INVESTIGATION. THE DESIGN OF THE GENIOPLASTY MARKING GUIDE WAS REVISED IN PROCESS (REMOVAL OF TWO (2) MARKING HOLES FOR CUSTOM PLATE FIXATION) AND THE CASE REPORT WAS NOT PROPERLY UPDATED TO DOCUMENT THE DESIGN REVISION. A TITANIUM ALLOY GENIOPLASTY MARKING GUIDE, FOR USE TO INTERFACE WITH SURGICAL CUTTING AND DRILLING TOOLS, WAS PROVIDED WITH THE CASE. GUIDANCE FOR USE OF POLYAMIDE AND TITANIUM GUIDES WAS PROVIDED IN THE OPERATIVE TECHNIQUE SECTION OF THE CASE REPORT. THE SURGICAL OUTCOME WAS SUCCESSFUL WITH NO ADVERSE AFFECT TO THE PATIENT.

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

  MAUDE report 11135470 ↗

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