VSP System Mandible Cutting GuideRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00816847020817), received between Mar 8, 2022 and Jun 22, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 13 most recent of 13 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 21148898 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A MAXILLOFACIAL PROCEDURE UTILIZING VSP SYSTEMS DEVICES, SURGICAL DIFFICULTY WAS REPORTED WHICH CAUSED THE PROCEDURE TO BE ENDED PREMATURELY. THE LEFORT PORTION OF THE PROCEDURE WAS NOT COMPLETED AND THE RIGHT MANDIBLE IMPLANT WAS NOT PLACED, REQUIRING AN ADDITIONAL SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 19615998 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A MAXILLOFACIAL PROCEDURE IN WHICH VSP SYSTEMS DEVICES WERE UTILIZED, THE PATIENT'S MANDIBLE DISLOCATED AND THE SURGEON PLANS TO DO A REVISION SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 19506621 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING THE USE OF A VSP SYSTEMS CUTTING GUIDE, THE HOLES ON THE PATIENT'S LEFT DISTAL MANDIBLE WERE TOO LOW TO BE USED WITH THE CUSTOM PLATE. AS A RESULT, THE SURGEON DRILLED ADDITIONAL HOLES TO ALLOW FOR PROPER ALIGNMENT. NO SURGICAL DELAY WAS REPORTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822827 ↗
• InjuryJan 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DURING A SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE PROVIDED SURGICAL GUIDE HAD PREDICTIVE DRILLING HOLES THAT DID NOT ALIGN WITH THE CORRESPONDING MANDIBULAR IMPLANT. THIS WAS IDENTIFIED BY THE OPERATING SURGEON PRIOR TO THE UTILIZATION OF THE GUIDE. CONSEQUENTLY, THE SURGEON OPTED TO PROCEED WITH THE SURGERY WITHOUT EMPLOYING THE GUIDE AND SUCCESSFULLY COMPLETED THE PROCEDURE. WHILE THIS HAD THE POTENTIAL FOR PATIENT HARM, NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440387 ↗
• InjuryMay 12, 2023Malposition of Device; Malposition of Device

  A MEDICAL PROFESSIONAL EXPRESSED CONCERNS TO 3D SYSTEMS ABOUT THE OUTCOME OF A PREVIOUS SURGICAL PROCEDURE, CITING DISSATISFACTION WITH THE PLACEMENT OF THE JOINT AND FOSSA PROSTHESES. THIS SURGEON HAS RECOMMENDED A REVISION SURGERY TO RECTIFY THE PLACEMENT OF THE IMPLANTS. 3D SYSTEMS GUIDES AIDED IN THE PLACEMENT OF THE IMPLANTS IN QUESTION, AND THEREFORE, MAY HAVE CONTRIBUTED TO THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 16920085 ↗
• InjuryFeb 9, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  WHILE UTILIZING A VSP MANDIBLE CUTTING GUIDE, THE SURGEON INDICATED THE PLANNED OSTEOTOMY DID NOT MATCH THE OSTEOTOMY THAT A TEMPOROMANDIBULAR JOINT PROSTHESIS WAS DESIGN TO. THE SURGEON REPORTED A 90 MINUTE DELAY AS A RESULT OF THE DISCREPANCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16343801 ↗
• InjuryFeb 8, 2023Malposition of Device; Malposition of Device

  WHILE PERFORMING SURGERY TO PLACE TEMPOROMANDIBULAR JOINT PROSTHESES, THE SURGEON REPORTED THAT PREDICTIVE HOLES THAT WERE PREDRILLED UTILIZING A 3D SYSTEMS MANDIBLE CUTTING GUIDE DID NOT PROPERLY ALIGN TO THE PROTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330214 ↗
• InjuryMar 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DURING A VSP ORTHOGNATHIC SINGLE-JAW PROCEDURE, THE SURGEON HAD TO MANIPULATE THE CUSTOM PLATES TO ACHIEVE THE CORRECT OCCLUSION. THE SURGICAL DELAY WAS REPORTED TO BE 60 MINUTES OR LESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13695983 ↗

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