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AccuPlate MC-K035Recalls & reported problems

Medcad · MANDIBLE RECONSTRUCTION, SURGICAL PLANNING KIT WITH ACCUPLATE BUNDLE · Class 2 · Implant

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 00810007630410), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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

  • Malposition of Device1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionApr 18, 2023Malposition of Device; Malposition of Device

    SURGEON FOUND A ROUGHLY 5 MM GAP BETWEEN GRAFT ON THE PATIENT LEFT AND NATIVE MANDIBLE WHEN FIXATING A CUSTOM BONE PLATE TO THE MANDIBLE. SURGICAL REPRESENTATIVE REPORTED THAT THERE APPEARED TO BE NO ISSUE WITH THE PLATE-GRAFT / PLATE-MANDIBLE INTERFACE.

    Patient problems: Insufficient Information

    MAUDE report 16766052 ↗

Other Plate, Bone devices

All Plate, Bone devices →

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