VSP System Maxilla Cutting GuideRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816847020831), received between Feb 24, 2023 and Aug 20, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionMar 15, 2024Malposition of Device; Malposition of Device

  DURING A PROCEDURE UTILIZING VSP SYSTEMS PRODUCTS, IT WAS DISCOVERED THAT THE SURGICAL GUIDE WAS NOT DESIGNED TO PROPERLY FOLLOW THE SURGICAL PLAN, RESULTING IN AN OSTEOTOMY INCOMPATIBLE WITH THE INTENDED IMPLANT. THIS HAS NECESSITATED THE PLANNING OF A REVISION SURGERY TO COMPLETE THE IMPLANTATION.

  Patient problems: Loss of Range of Motion

  MAUDE report 18914128 ↗
• InjuryFeb 24, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  WHILE PERFORMING SURGERY TO PLACE A TEMPOROMANDIBULAR JOINT PROSTHESES, THE SURGEON REPORTED THAT PREDICTIVE HOLES THAT WERE PREDRILLED UTILIZING A 3D SYSTEMS MAXILLA CUTTING GUIDE DID NOT PROPERLY POSITION A FOSSA PROTHESIS. THE SURGEON NEEDED TO REMOVE THE PROTHESIS ALONG WITH THE SCREWS FIXATING IT AND ADJUST THE POSITION OF THE FOSSA PROSTHESIS AS A RESULT. THE SURGEON REPORTED THE GUIDE DID NOT ADEQUATELY ENGAGE THE PATIENT'S ANATOMY TO REGISTER THE GUIDE IN THE ANTERIOR/POSTERIOR DIRECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436720 ↗

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