Skip to content

AccuPlan System MC-K000Recalls & reported problems

Medcad · ORTHOGNATHIC, SURGICAL PLANNING KIT · Class 2

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 00810007630298), received between Jul 6, 2022 and Jul 6, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Improper or Incorrect Procedure or Method1
  • Incorrect, Inadequate or Imprecise Result or Readings1
  • Insufficient Device Problem Information1

Patient problems

  • Nerve Damage1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 6, 2022Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT'S RIGHT INFERIOR ALVEOLAR NERVE WAS DAMAGED DURING THE SAGITTAL SPLIT OSTEOTOMY.

    Patient problems: Nerve Damage

    MAUDE report 14941154 ↗

Other Driver, Wire, And Bone Drill, Manual devices

All Driver, Wire, And Bone Drill, Manual devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.