ProPlan CMFRecalls & reported problems across all models

We found 10 models of ProPlan CMF by Materialise NV in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between Sep 7, 2017 and Mar 30, 2026 — classified as 11 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ProPlan CMF recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

2. Jul 13, 2022Completed

   MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK

   Z-1569-2022 · Root cause: Employee error · Recall details · FDA record ↗

Most reported ProPlan CMF problems

ProPlan CMF models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ProPlan CMF SD900.101

  Plate, Bone
  1 recall1 report
• ProPlan CMF SD900.208

  Template
  1 recall0 reports
• ProPlan CMF SD900.008

  Template
  3 reports
• ProPlan CMF SD900.105

  Template
  3 reports
• ProPlan CMF SD900.001

  Plate, Bone
  2 reports
• ProPlan CMF SD900.106

  Template
  2 reports
• ProPlan CMF SD900.008

  Plate, Bone
  1 report
• ProPlan CMF SD900.051

  Plate, Bone
  1 report
• ProPlan CMF SD900.102

  Plate, Bone
  1 report
• ProPlan CMF SD900.111

  Plate, Bone
  1 report

Recent ProPlan CMF adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE SPLINTS DID NOT FIT, AND THE SURGERY WAS ABORTED. ADDITIONAL SURGICAL INTERVENTION IS NEEDED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714268 ↗
• 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 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON HAS REPORTED THAT THE INTERMEDIATE SPLINT DIDN'T FIT AND THE DESIRED OCCLUSION WAS NOT ACHIEVED, THE REVISION SURGERY IS REQUIRED TO CORRECT OCCLUSION.

  Patient problems: Physical Asymmetry

  MAUDE report 20470560 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGERY RESULTED IN A POSTERIOR OPEN BITE. CORRECTIVE SURGERY IS REQUIRED.

  Patient problems: Physical Asymmetry

  MAUDE report 19654392 ↗
• MalfunctionDec 21, 2023Positioning Problem; Patient Device Interaction Problem; Positioning Problem; Patient Device Interaction Problem

  KNEE AND FOOT MARKINGS ON FIBULA GUIDE WERE REVERSED. NO INJURY OR NEED FOR REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371009 ↗
• MalfunctionDec 1, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT ON FIBULA GUIDE LABELS FOR KNEE/ANKLE WERE SWAPPED. THIS WAS NOTICED IMMEDIATELY DURING SURGERY, THERE WAS NO PATIENT HARM INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18252470 ↗
• 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 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN FOLLOW-UP MEETING WITH PATIENT, MIDLINE WAS 5MM OFF CENTER AND THERE WAS SIGNIFICANT YAW.

  Patient problems: Physical Asymmetry

  MAUDE report 16931511 ↗
• InjuryJul 6, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  INTERMEDIATE SPLINT DID NOT LEAD TO DESIRED MANDIBLE POSITION. SURGERY HAD TO BE STOPPED AND COMPLETED THE FOLLOWING DAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14926836 ↗
• MalfunctionApr 27, 2022Positioning Problem; Patient Device Interaction Problem; Positioning Problem; Patient Device Interaction Problem

  KNEE AND FOOT MARKINGS ON FIBULA GUIDE WERE REVERSED. NO INJURY OR NEED FOR REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14216828 ↗
• 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 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MAXILLA AND MANDIBLE MIDDLINE NOT AS PLANNED AFTER SURGERY.

  Patient problems: Physical Asymmetry

  MAUDE report 12014699 ↗
• InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORAL SURGERY USING PATIENT SPECIFIC GUIDES. CUTS WERE MADE INTO THE TOOTH AND NERVE. THE PATIENT HAD TOOTH AND ROOT DAMAGE. NERVE WAS ANASTOMOSED.

  Patient problems: Nerve Damage

  MAUDE report 7989029 ↗
• InjuryMar 2, 2018Failure to Align; Failure to Align

  A PATIENT SPECIFIC GUIDE WAS USED TO PERFORM A MANDIBLE RECONSTRUCTION. IT WAS REPORTED THAT THE HOLES PRE-DRILLED WITH THE GUIDE DID NOT MATCH UP WITH THE HOLES OF THE PLATE USED IN SURGERY. A DELAY OF AROUND 1 HOUR IN SURGERY WAS REPORTED. SURGEON REPORTED THAT OCCLUSION MAY BE AN ISSUE, BONE SEGMENTS MAY NOT UNITE AS WELL, IMPLANT DIRECTION NOT OPTIMAL, ONLY TWO, INSTEAD OF 4 IMPLANTS WERE PLACED, MORE MANIPULATION OF THE FIBULA SEGMENTS THAT MAY COMPROMISE PART OF FLAP SURVIVAL. SURGEON REPORTED THAT ANOTHER SURGERY WILL BE REQUIRED.

  Patient problems: No Code Available

  MAUDE report 7309143 ↗
• InjurySep 7, 2017Break; Break

  WHEN WIRING THE FINAL SPLINT THE ANTERIOR AREA OF THE SPLINT BROKE AROUND THE WIRING HOLES. THE SURGEON INDICATED THAT THE EVENT DID NOT RESULT IN INJURY OR HARM TO THE PATIENT. THE PATIENT NEEDED A REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 6848040 ↗

Other Materialise NV products

• TruMatch14 models · 139 reports · 2 recalls
• Zimmer Biomet Patient Specific Instruments2 models · 1 reports · 1 recall