VSP System Surgical SplintRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816847020510), received between Jan 12, 2022 and Jun 18, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Compatibility 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A MAXILLOFACIAL SURGICAL PROCEDURE UTILIZING VSP SYSTEMS PRODUCTS WAS CANCELED DUE TO A REPORTED SURGICAL SPLINT FIT CONCERN AFTER INCISIONS WERE MADE, PREVENTING THE SURGEON FROM PROCEEDING WITH OSTEOTOMIES. DIGITAL REVIEWS WERE UNABLE TO REPLICATE THE REPORTED FIT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288138 ↗
• InjuryJan 12, 2022Device-Device Incompatibility; Compatibility Problem; Device-Device Incompatibility; Compatibility Problem

  FOR A VSP ORTHOGNATHIC PROCEDURE, THE SURGEON WAS NOT ABLE ACHIEVE A FLUSH FIT AT THE CONNECTING POINT BETWEEN TWO HYBRID VSP 2.0 GUIDES (NYLON INITIAL SURGICAL SPLINT AND TITANIUM RIGHT MAXILLA CUTTING GUIDE). AS A RESULT, THE SURGEON HAD TO REPLATE THE PATIENT'S MAXILLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236689 ↗

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