CMF VISIONARE 1.904.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810004511170), received between Dec 30, 2024 and Dec 30, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Break; Break

  ACCORDING TO THE HEALTH PROFESSIONAL DESCRIPTION: "DURING THE YEAR 2024, (B)(4) COMPANY STARTED THE EXCLUSIVE SUPPLY OF ORTHOSES, PROSTHESES AND SPECIAL FIXATION MATERIALS FOR THE SPECIALTY OF BUCO-MAXILO-FACIAL, WITH THE SUPPLY OF VISIONARE BRAND FIXING PLATES. DURING THIS PERIOD, I NOTICED A SIGNIFICANT INCREASE IN PATIENTS WHO EVOLVED TO FRACTURE OF THE PLATES INSTALLED IN THE JAW, WITHOUT APPARENT REASON. THE FRACTURE OF THE FIXATION PLATES CAN INTERFERE WITH THE HEALING OF THE JAW, CAUSING BAD OCCLUSIONS, PSEUDOARTHROSIS, OSTEOMYELITIS, AMONG OTHER PROBLEMS, WHICH WILL OFTEN BE SOLVED WITH NEW SURGICAL INTERVENTIONS." COMPLAINT OCCURRED IN BRAZILIAN MARKET. THIS CONTENT WAS TRANSLATED FROM PORTUGUESE TO ENGLISH BY VISIONARE. THE ORIGINAL COMPLAINT REPORTED 4 PLATES BROKEN, HOWEVER, DATA FROM ONLY 3 PATIENTS WERE SHARED. THIS OCCURRENCE GENERATED THE NEED TO NOTIFY ADVERSE EVENTS TO ANVISA THROUGH NOTIFICATION NO. (B)(4). THIS EVENT WILL BE ACCOUNTED FOR AND MONITORED THROUGH POST-MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS THERE ARE OCCURRENCES WITH 3 DIFFERENT PATIENTS, THE COMPANY WILL MAKE

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21037156 ↗
• InjuryDec 30, 2024Break; Break

  ACCORDING TO THE HEALTH PROFESSIONAL DESCRIPTION: "DURING THE YEAR 2024, (B)(6) COMPANY STARTED THE EXCLUSIVE SUPPLY OF ORTHOSES, PROSTHESES AND SPECIAL FIXATION MATERIALS FOR THE SPECIALTY OF BUCO-MAXILO-FACIAL, WITH THE SUPPLY OF VISIONARE BRAND FIXING PLATES. DURING THIS PERIOD, I NOTICED A SIGNIFICANT INCREASE IN PATIENTS WHO EVOLVED TO FRACTURE OF THE PLATES INSTALLED IN THE JAW, WITHOUT APPARENT REASON. THE FRACTURE OF THE FIXATION PLATES CAN INTERFERE WITH THE HEALING OF THE JAW, CAUSING BAD OCCLUSIONS, PSEUDOARTHROSIS, OSTEOMYELITIS, AMONG OTHER PROBLEMS, WHICH WILL OFTEN BE SOLVED WITH NEW SURGICAL INTERVENTIONS." COMPLAINT OCCURRED IN BRAZILIAN MARKET. THIS CONTENT WAS TRANSLATED FROM PORTUGUESE TO ENGLISH BY VISIONARE. THE ORIGINAL COMPLAINT REPORTED 4 PLATES BROKEN, HOWEVER, DATA FROM ONLY 3 PATIENTS WERE SHARED. THIS OCCURRENCE GENERATED THE NEED TO NOTIFY ADVERSE EVENTS TO ANVISA THROUGH NOTIFICATION NO. (B)(4). THIS EVENT WILL BE ACCOUNTED FOR AND MONITORED THROUGH POST-MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS THERE ARE OCCURRENCES WITH 3 DIFFERENT PATIENTS, THE COMPANY WILL MAKE

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21037149 ↗
• InjuryDec 30, 2024Break; Break

  ACCORDING TO THE HEALTH PROFESSIONAL DESCRIPTION: "DURING THE YEAR 2024, MEDICAL COMPANY STARTED THE EXCLUSIVE SUPPLY OF ORTHOSES, PROSTHESES AND SPECIAL FIXATION MATERIALS FOR THE SPECIALTY OF BUCO-MAXILO-FACIAL, WITH THE SUPPLY OF VISIONARE BRAND FIXING PLATES. DURING THIS PERIOD, I NOTICED A SIGNIFICANT INCREASE IN PATIENTS WHO EVOLVED TO FRACTURE OF THE PLATES INSTALLED IN THE JAW, WITHOUT APPARENT REASON. THE FRACTURE OF THE FIXATION PLATES CAN INTERFERE WITH THE HEALING OF THE JAW, CAUSING BAD OCCLUSIONS, PSEUDOARTHROSIS, OSTEOMYELITIS, AMONG OTHER PROBLEMS, WHICH WILL OFTEN BE SOLVED WITH NEW SURGICAL INTERVENTIONS." COMPLAINT OCCURRED IN BRAZILIAN MARKET. THIS CONTENT WAS TRANSLATED FROM PORTUGUESE TO ENGLISH BY VISIONARE. THE ORIGINAL COMPLAINT REPORTED 4 PLATES BROKEN, HOWEVER, DATA FROM ONLY 3 PATIENTS WERE SHARED. THIS OCCURRENCE GENERATED THE NEED TO NOTIFY ADVERSE EVENTS TO ANVISA THROUGH NOTIFICATION NO. 2024.12.003663 23.12.24. THIS EVENT WILL BE ACCOUNTED FOR AND MONITORED THROUGH POST-MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS THERE ARE OCCURRENCES WITH 3 DIFFERENT PATIENTS, THE

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21037143 ↗