VSP SystemRecalls & reported problems across all models

We found 14 models of VSP System by 3d Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2016 and Jun 22, 2026 — classified as 53 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (8 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

VSP System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 17, 2022Open, Classified

   Scapula Marking Guide (anatomically Shaped) was incorrectly designed.

   Z-1510-2022 · Root cause: Employee error · Recall details · FDA record ↗

Most reported VSP System problems

VSP System models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VSP System Scapula Marking Guide

  System, Image Processing, Radiological
  1 recall0 reports
• VSP System Mandible Cutting Guide

  Driver, Wire, And Bone Drill, Manual
  13 reports
• VSP System Mandible Marking Guide

  System, Image Processing, Radiological
  7 reports
• VSP System Intermediate Surgical Splint

  Driver, Wire, And Bone Drill, Manual
  6 reports
• VSP System Final Surgical Splint

  System, Image Processing, Radiological
  6 reports
• VSP System Fibula Cutting Guide with Implant Placement

  Driver, Wire, And Bone Drill, Manual
  6 reports
• VSP System Fibula Cutting Guide

  Driver, Wire, And Bone Drill, Manual
  5 reports
• VSP System Maxilla Cutting Guide

  Driver, Wire, And Bone Drill, Manual
  4 reports
• VSP System LeFort Marking Guide

  Driver, Wire, And Bone Drill, Manual
  3 reports
• VSP System Surgical Splint

  System, Image Processing, Radiological
  2 reports
• VSP System Sagittal Split Marking Guide

  Driver, Wire, And Bone Drill, Manual
  1 report
• VSP System Genioplasty Drilling Guide

  Driver, Wire, And Bone Drill, Manual
  1 report
• VSP System Genioplasty Marking Guide

  Driver, Wire, And Bone Drill, Manual
  1 report
• VSP System Maxilla Marking Guide

  System, Image Processing, Radiological
  1 report

Recent VSP System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  DURING SURGERY, MANDIBLE GUIDES WITH PHP WERE USED MARK THE PREDICTIVE HOLES AND TO PLACE THE MANDIBULAR COMPONENT OF THE PROTHESIS. WHEN PLACED ONTO THE DRILLED HOLES, THE CUSTOM MANDIBULAR COMPONENT OF THE PROTHESIS WAS INTERFERING WITH THE POSTERIOR FOSSA COMPONENT, CAUSING THE INTERMEDIATE SPLINT TO NOT FIT APPROPRIATELY. THIS LED TO THE SURGEON HAVING TO DRILL NEW HOLES FOR THE MANDIBULAR COMPONENT AND REPLACING IT IN A SPOT WHERE IT WOULD NOT INTERFERE WITH THE FOSSA COMPONENT. SURGEON SAID THE GUIDES FIT FINE. A POST OP STUDY WILL BE DONE TO DETERMINE WHERE THE PREDICTIVE HOLES WERE DRILLED COMPARED TO THE GUIDED POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25586206 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  WHILE PERFORMING THE VERTICAL OSTEOTOMY OF THE BSSO, THE RESIDENT ASSUMED THE CUTTING SLOT ENDED AT THE INFERIOR BORDER AND CONTINUED CUTTING BASED OFF THAT. CONFUSION ALSO AROSE WHEN LOOKING AT THE NERVE TO DISTAL MANDIBLE MEASUREMENTS IN THE CASE REPORT AS THE RESIDENT BELIEVED THERE SHOULD'VE BEEN TWO MEASUREMENTS - ONE AT THE ANTERIOR CUT OF THE WEDGE AND ANOTHER AT THE POSTERIOR. THESE COMBINED RESULTED IN THE PATIENTS NERVES BEING SEVERED BILATERALLY.

  Patient problems: Nerve Damage

  MAUDE report 24617726 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED DIFFICULTIES DURING A MAXILLOFACIAL PROCEDURE INVOLVING VSP SYSTEM DEVICES. SURGICAL COMPLICATIONS RELATED TO THE FIT OF THE CUSTOM PLATES RESULTED IN THE SCHEDULING OF A REVISION SURGERY TO ADDRESS CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279956 ↗
• 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 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 30-45 MINUTE DELAY WAS CAUSED FROM BURRING THE FIBULA SEGMENTS TO FIT THE PLATE. THE SURGEON INDICATED HE SHIFTED THE GUIDE ON THE FIBULA. THE GUIDE REGISTERED WELL BUT LIKELY IN A DIFFERENT ROTATION. THE PATIENT WILL REQUIRE A REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823207 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A MAXILLOFACIAL PROCEDURE INVOLVING VSP SYSTEMS DEVICES, THE SURGEON REPORTED DRILLING ADDITIONAL HOLES IN THE PATIENT ANATOMY IN ORDER TO FIT A CUSTOM PLATE AND ACHIEVE THE DESIRED DENTAL OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23651664 ↗
• InjuryNov 14, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING A MAXILLOFACIAL PROCEDURE UTILIZING VSP SYSTEM SURGICAL GUIDES, A COMPLICATION DURING THE GENIOPLASTY RESULTED IN ADDITIONAL HOLES BEING DRILLED TO ACCOMODATE THE TITANIUM PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555998 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A MAXILLOFACIAL PROCEDURE INVOLVING VSP SYSTEM DEVICES, THE SURGEON WAS UNABLE TO ACHIEVE THE INTENDED OCCLUSION USING AN IMPLANT PROVIDED BY ANOTHER COMPANY, REQUIRING ADDITIONAL HOLES TO BE DRILLED IN ORDER TO COMPLETE THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535141 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A MAXILLOFACIAL SURGERY INVOLVING VSP SYSTEM DEVICES, THE SURGEON REPORTED THAT THE LEFT MAXILLA GUIDE WAS NOT SEATING PROPERLY ON THE PATIENT'S BONY ANATOMY AND THE SURGEON DECIDED NOT TO PROCEED WITH THE OPERATION.

  Patient problems: Laceration(s)

  MAUDE report 22851702 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A MAXILLOFACIAL SURGERY INVOLVING THE IMPLANTATION OF A CUSTOM INPLANT, THE SURGEON REPORTED THAT THE IMPLANT WAS NOT SEATING PROPERLY ON THE PATIENT ANATOMY AND THE SURGEON WAS UNABLE TO COMPLETE THE PROCEDURE AS PLANNED. VSP SYSTEM SURGICAL MARKING GUIDES WERE PROVIDED BY 3D SYSTEMS TO ASSIST THE SURGEON IN THE PROCEDURE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22542824 ↗
• 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 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A MAXILLOFACIAL PROCEDURE INVOLVING VSP SYSTEM GUIDES, IT WAS REPORTED THAT THE MAXILLARY PLATES RESULTED IN A DEVIATED DENTAL MIDLINE. THESE PATIENT SPECIFIC PLATES WERE REMOVED, AND STOCK PLATES WERE USED TO CORRECT THE MAXILLARY POSITION. THIS REQUIRED THE DRILLING OF ADDITIONAL HOLES TO PROPERLY SECURE THE STOCK PLATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858645 ↗
• 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 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING THE USE OF VSP SYSTEM CUTTING GUIDES, THE HOLES ON THE PATIENT'S MANDIBLE DID NOT PROPERLY ALIGN TO THE CUSTOM PLATE. AS A RESULT, THE SURGEON DRILLED ADDITIONAL HOLES TO ALLOW FOR PROPER PLACEMENT. MINIMAL SURGICAL DELAY WAS REPORTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148914 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING THE USE OF VSP SYSTEM CUTTING GUIDES, THE HOLES ON THE PATIENT'S MANDIBLE DID NOT PROPERLY ALIGN TO THE CUSTOM PLATE. AS A RESULT, THE SURGEON DRILLED ADDITIONAL HOLES TO ALLOW FOR PROPER PLACEMENT. MINIMAL SURGICAL DELAY WAS REPORTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148910 ↗