VSP System Mandible Marking GuideRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00816847020824), received between Jun 30, 2022 and Mar 17, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJun 18, 2024Malposition of Device; Malposition of Device

  FOLLOWING A MAXILLOFACIAL PROCEDURE UTILIZING VSP SYSTEMS PRODUCTS, IT WAS REPORTED THAT THE SURGEON WAS UNHAPPY WITH THE SURGICAL OUTCOME AND INTENDS TO PERFORM A REVISION SURGERY. IN PARTICULAR, THE SURGEON NOTED DIFFICULTY UTILIZING THE PROVIDED MANDIBLE CUTTING GUIDES.

  Patient problems: Failure of Implant

  MAUDE report 19559935 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A MAXILLOFACIAL PROCEDURE UTILIZING VSP SYSTEMS PRODUCTS, IT WAS REPORTED THAT THE SURGEON HAD OPERATIVE DIFFICULTIES UTILIZING THE PROVIDED 3D SYSTEMS MANDIBLE MARKING GUIDE AND SUBSEQUENT DIFFICULTIES IN THE PLACEMENT OF THE MANDIBLE PROSTHESIS. THIS RESULTED IN AN OPERATIVE DELAY OF MORE THAN TWO HOURS AND IT HAS BEEN REPORTED THAT A REVISION SURGERY IS BEING PLANNED.

  Patient problems: Failure of Implant

  MAUDE report 19383290 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A MAXILLOFACIAL SURGERY, IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY FITTING A MANDIBLE PROSTHESIS TO THE PATIENT USING A 3D SYSTEMS MANDIBLE MARKING GUIDE, WHICH CAUSED A DELAY IN THE OPERATION OF APPROXIMATELY 4 HOURS. THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175138 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CONDYLECTOMY PROCEDURE, A SURGEON REPORTED DISCOVERING A MISALIGNMENT BETWEEN THE PREDICTED SCREW HOLE LOCATIONS OF A 3D SYSTEM'S DEVICE AND THE PATIENT'S ANATOMY. ADDITIONAL HOLES WERE DRILLED IN THE PATIENT'S MANDIBLE TO ENSURE PROPER IMPLANT PLACEMENT. POST-PROCEDURE INVESTIGATION REVEALED NO IDENTIFIABLE PRODUCT OR PROCESS DEFICIENCIES THAT WOULD ACCOUNT FOR THIS MIS-ALIGNMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141891 ↗
• InjuryJun 30, 2022Malposition of Device; Malposition of Device

  DURING A VSP ORTHOGNATHICS AND TMJ SURGERY, THERE WERE ISSUES WITH THE FIT OF THE MANDIBULAR PROSTHESIS. THE SURGEON DRILLED THE PREDICTIVE HOLES INDICATED BY THE MANDIBLE MARKING GUIDE AND LATER FOUND THAT THE MANDIBULAR PROSTHESIS WOULD NOT MEET THE FOSSA ONCE IT WAS SCREWED INTO THE MANDIBLE. AS A RESULT, THE SURGEON DID NOT USE THE PRE-DRILLED HOLES AND PREFERRED A DIFFERENT POSITIONING OF THE MANDIBLE PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881088 ↗

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