AccuPlan System MC-KT011Recalls & reported problems
Medcad · MANDIBLE RECONSTRUCTION, TITANIUM SURGICAL GUIDE · Class 2
- 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 00810007631240), received between Feb 25, 2026 and Mar 5, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Positioning Problem” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Positioning Problem2
- Inadequacy of Device Shape and/or Size1
- Patient-Device Incompatibility1
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 5, 2026Patient-Device Incompatibility; Positioning Problem
GUIDES DID NOT FIT DURING THE SURGICAL PROCEDURE, REVISION SURGERY REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519487 ↗MalfunctionFeb 25, 2026Inadequacy of Device Shape and/or Size; Positioning Problem
TITANIUM MANDIBLE AND FOSSA GUIDES DID NOT FIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24444608 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.