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ProPlan CMF SD900.101Recalls & reported problems

Materialise NV · Patient Specific Guide, Mandible · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420060351013), received between Jun 30, 2023 and Jun 30, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

  1. Jun 19, 2023Completed

    Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

    Z-2287-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Difficult or Delayed Positioning1

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.

  • InjuryJun 30, 2023Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT GUIDES DID NOT FIT. APPROXIMATELY 3 WEEKS LATER REVISION SURGERY NEEDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17235889 ↗

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.