VSP System Final Surgical SplintRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816847020541), received between Aug 12, 2020 and Feb 4, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  DURING A MAXILLOFACIAL PROCEDURE INVOLVING VSP SYSTEM DEVICES, THE SURGEON REPORTED THAT THE PRE-DRILLED HOLES FOR THE CUSTOM PLATE DID NOT PROPERLY ALIGN, LEADING TO ADDITIONAL HOLES BEING DRILLED IN THE PATIENT'S MAXILLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260418 ↗
• InjuryFeb 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  WHILE PERFORMING CORRECTIVE JAW SURGERY UTILIZING VSP SYSTEMS' LEFORT DRILLING GUIDE AND SURGICAL SPLINTS, THE SURGEON REPORTED THE LEFORT DRILLING GUIDE AND SURGICAL SPLINT DID NOT FIT AS ANTICIPATED. ADDITIONALLY, THE SURGEON REPORTED THAT THE SPLINTS NEEDED TO BE ALTERED IN THE OPERATING ROOM TO ACHIEVE A SATISFACTORY FIT. THESE ISSUES CONTRIBUTED TO A SURGICAL DELAY OF 120+ MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16391090 ↗
• InjuryFeb 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ORTHOGNATHIC SURGICAL PROCEDURE, THE SURGEON HAD DIFFICULTY USING THE INTERMEDIATE AND FINAL SURGICAL SPLINT TO SET THE PATIENT'S FINAL OCCLUSION. THIS RESULTED IN A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2022 SO THE SURGEON COULD FIX THE PATIENT'S OCCLUSION.

  Patient problems: Malunion of Bone

  MAUDE report 16380910 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A COMBINATION CASE INVOLVING VIRTUAL SURGICAL PLANNING (VSP) AND STRYKER TMJ-CONCEPTS, THE SURGEON REPORTED A MALOCCLUSION AFTER PLACEMENT OF THE FINAL SURGICAL SPLINT. THE SURGEON REPORTED A 90-MINUTE DELAY IN SURGERY AS THEY ATTEMPTED TO ADJUST THE PATIENT'S OCCLUSION INTRAOPERATIVELY.

  Patient problems: Joint Dislocation

  MAUDE report 15826424 ↗
• InjuryMar 24, 2022Product Quality Problem; Product Quality Problem

  THE VSP SYSTEM FINAL SURGICAL SPLINT DID NOT FIT THE SURGEON'S PLANNED FINAL POSITION OF THE PATIENT'S MANDIBLE DURING A VSP ORTHOGNATHIC TMJ SURGERY. THE SURGICAL DELAY WAS REPORTED TO BE 1-2 HOURS FOR ACHIEVING THE SPLINT TO FIT THE PATIENT'S FINAL OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13891031 ↗
• InjuryAug 12, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SURGEON REPORTED THE VSP SYSTEM FINAL SURGICAL SPLINT AND FINAL PALATAL SPLINT DID NOT MATCH THE SURGEON'S PLANNED FINAL POSITION OF THE PATIENT'S MAXILLA FOR THE MAXILLARY/CONDYLECTOMY ORTHOGNATHIC SURGERY.

  Patient problems: No Code Available

  MAUDE report 10396979 ↗

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