AccuPlan System ZB-KT001-HRecalls & reported problems
Medcad · ORTHOGNATHIC, TITANIUM HYBRID SURGICAL GUIDE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810007631219), received between Sep 12, 2025 and Mar 10, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Positioning Problem
THE PREDICTIVE HOLES DIDN'T ALIGN WITH THE PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24558477 ↗MalfunctionSep 12, 2025Break; Break
THE RESIN HYBRID GUIDES BROKE DURING THE PROCEDURE. AS IT IS UNCLEAR WHICH SIDE (LEFT OR RIGHT) FAILED, BOTH SIDES ARE BEING REPORTED FOR COMPLETENESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23039316 ↗
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
- NA 03.505.007Synthes GmbH · DRIVER, WIRE, AND BONE DRILL, MANUAL6 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
- VSP System Fibula Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual5 reports
- VSP System Maxilla Cutting Guide3d Systems, Inc. · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page