VSP System Intermediate Surgical SplintRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816847020534), received between Jun 21, 2019 and Jan 24, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

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.

• InjuryJan 24, 2025Use of Device Problem; Use of Device Problem

  A SURGEON REPORTED THAT FOLLOWING A PROCEDURE THAT UTILIZED VSP SYSTEM, THE PATIENT SPECIFIC PROSTHESIS DID NOT END UP IN THE PROPER POSITION POST-SURGERY. THE PATIENT REPORTED DISCOMFORT WHICH LED TO A REVISION SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 21231338 ↗
• MalfunctionJul 14, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A MEDICAL PROFESSIONAL REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS DISCOVERED THAT ONE OF THE DEVICES PROVIDED BY 3D SYSTEMS HAD NOT BEEN PROPERLY LABELED FOR THE PLANNED PROCEDURE WHICH RESULTED IN THE DEVICE NOT BEING USED. THE LABEL FOR THE DEVICE IN QUESTION DID NOT MATCH THE PLAN PRESENT IN THE CASE REPORT AS IT WAS LABELED FOR A MAXILLA FIRST SURGERY WHILE THE CASE WAS PLANNED TO BE A MANDIBLE FIRST PROCEDURE. NO PATIENT HARM WAS REPORTED AND THE SURGEON REPORTED NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17326317 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOR A VSP/TMJ COMBINATION CASE, THE VSP SYSTEM INTERMEDIATE SPLINT COULD HAVE CONTRIBUTED TO A DEVIATED IMPLANT POSITIONING FOR A BILATERAL JOINT REVISION SURGERY RESULTING IN MALPOSITIONED TMJ DEVICES ON THE PATIENT'S LEFT SIDE.

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

  MAUDE report 12763792 ↗
• InjuryJul 20, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE SURGEON REPORTED THE VSP SYSTEM INTERMEDIATE SPLINT DID NOT MATCH THE PLANNED INTERMEDIATE POSITION FOR THE PATIENT'S MAXILLA FOR DOUBLE JAW ORTHOGNATHIC SURGERY.

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

  MAUDE report 12197386 ↗
• InjuryApr 1, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE SURGEON REPORTED THE VSP SYSTEM INTERMEDIATE SPLINT DID NOT MATCH THE PLANNED INTERMEDIATE POSITION FOR THE PATIENT'S MANDIBLE FOR DOUBLE JAW ORTHOGNATHIC SURGERY.

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

  MAUDE report 11606111 ↗
• InjuryJun 21, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE SURGEON REPORTED THE INTERMEDIATE SURGICAL SPLINT DID NOT MATCH THE SURGEON'S PLANNED INTERMEDIATE POSITION OF THE PATIENT'S MAXILLA FOR THE MAXILLARY/MANDIBLE ORTHOGNATHIC SURGERY.

  Patient problems: No Code Available

  MAUDE report 8724030 ↗

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