VSP System Genioplasty Drilling GuideRecalls & reported problems
3d Systems, Inc. · A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes · Class 2
All models of VSP System (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816847020657), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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, Classified3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Other Driver, Wire, And Bone Drill, Manual devices
- NA 03.505.003Synthes GmbH · DRIVER, WIRE, AND BONE DRILL, MANUAL154 reports
- NA 5400007000Stryker Corporation · DRIVER, WIRE, AND BONE DRILL, MANUAL20 reports
- VSP System Mandible Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual13 reports
- VSP System Intermediate Surgical Splint3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual6 reports
- VSP System Fibula Cutting Guide with Implant Placement3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual6 reports
- NA 03.505.007Synthes GmbH · DRIVER, WIRE, AND BONE DRILL, MANUAL6 reports
- VSP System Fibula Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual5 reports
- NA 03.505.041Synthes GmbH · DRIVER, WIRE, AND BONE DRILL, MANUAL4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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