ProPlan CMF SD900.106Recalls & reported problems
Materialise NV · Splint, Orthognathic, Final (Clear Acrylic) · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05420060351167), received between Aug 30, 2021 and Dec 2, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Physical Asymmetry1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
WHEN PLACING IN THE FINAL SPLINT, IT BECAME APPARENT THAT THE FINAL OCCLUSION WAS NOT AS PLANNED, MIDLINE WAS OFF BY 2MM. SURGEON WILL BE LOOKING AT THE PATIENT POST SURGERY WHICH WILL MOST LIKELY LEAD TO A NEED OF REVISION SURGERY.
Patient problems: Physical Asymmetry
MAUDE report 20817700 ↗InjuryAug 30, 2021Fracture; Fracture
PALATAL SPLINT BROKE AND COULD NOT BE USED, ADDITIONAL TREATMENT TO PLACE NEW SPLINT NEEDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12382006 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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