Skip to content

AccuPlan System MC-K011Recalls & reported problems

Medcad · MANDIBLE RECONSTRUCTION, SURGICAL GUIDE · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810007630366), received between Jun 3, 2022 and Jun 3, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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

  • Inadequacy of Device Shape and/or Size1

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.

  • MalfunctionJun 3, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE PATIENT MATCHED SURGICAL GUIDE DID NOT FIT THE PATIENT AT THE TIME OF SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14595421 ↗

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.