Vistafix 93100Recalls & reported problems
Cochlear Bone Anchored Solutions AB · Cochlear™ Vistafix® VXI300 Implant 3mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 09321502021715), received between Nov 22, 2017 and Feb 19, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
- Patient Device Interaction Problem2
- Loss of Osseointegration1
Patient problems
- Host-Tissue Reaction3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Bacterial Infection2
- Inadequate Osseointegration1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY UNDER GENERAL ANESTHESIA (DATE NOT REPORTED) IN ORDER TO EXCISE THE SKIN AROUND THE ABUTMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21407552 ↗InjuryFeb 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT UNDERWENT A SKIN REVISION SURGERY UNDER GENERAL ANESTHESIA (DATE NOT REPORTED) IN ORDER TO EXCISE THE SKIN AROUND THE ABUTMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21407520 ↗InjuryJun 8, 2022Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION OF THE IMPLANT. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT WITH ANOTHER DEVICE.
Patient problems: Inadequate Osseointegration
MAUDE report 14640183 ↗InjuryDec 5, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND SKIN OVER-GROWTH AT THE IMPLANT SITE AND WAS SUBSEQUENTLY TREATED WITH AN ANTIBIOTIC OINTMENT. THE PATIENT CONTINUES TO BE CLINICALLY MANAGED BY THEIR HEALTHCARE PROVIDER. THE IMPLANTED DEVICE REMAINS INSITU.
Patient problems: Bacterial Infection; Host-Tissue Reaction
MAUDE report 7084499 ↗InjuryNov 30, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND SKIN OVER-GROWTH AT THE IMPLANT SITE AND WAS SUBSEQUENTLY TREATED WITH AN ANTIBIOTIC OINTMENT.
Patient problems: Bacterial Infection; Host-Tissue Reaction
MAUDE report 7073851 ↗InjuryNov 22, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT ABUTMENT SITE; SUBSEQUENTLY THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND UNDERWENT SKIN REVISION SURGERY DURING AN ABUTMENT CHANGE. THE IMPLANTED DEVICE REMAINS.
Patient problems: Host-Tissue Reaction
MAUDE report 7055068 ↗
Other PROSTHESIS, NOSE, INTERNAL devices
- IMP. EPIKUT MT16° Ø3,5X15,0MM ILM 3515Sin Sistema de Implante Nacional S/A · Prosthesis, Nose, Internal1 recall0 reports
- Vistafix 93101Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL14 reports
- Vistafix 92997Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL8 reports
- Vistafix 92996Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL6 reports
- Vistafix 92995Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL4 reports
- Vistafix 92998Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL4 reports
- Fixture ST 4mm 90440Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL2 reports
- Fixture ST 3mm 90438Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL2 reports
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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