Vistafix 92998Recalls & reported problems
Cochlear Bone Anchored Solutions AB · Cochlear™ Vistafix® VXA300 Healing abutment · Class 2 · Implant
All models of Vistafix (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09321502021708), received between Nov 10, 2021 and Nov 10, 2021 — classified as 4 injuries.
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 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available4
Patient problems
- Skin Inflammation/ Irritation4
- Unspecified Infection4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND SKIN IRRITATION ON THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED) AND SUBSEQUENTLY, WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2021, IN ORDER TO REMOVE THE ABUTMENT. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).
Patient problems: Skin Inflammation/ Irritation; Unspecified Infection
MAUDE report 12785122 ↗InjuryNov 10, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND SKIN IRRITATION ON THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED) AND SUBSEQUENTLY, WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2021, IN ORDER TO REMOVE THE ABUTMENT. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).
Patient problems: Skin Inflammation/ Irritation; Unspecified Infection
MAUDE report 12785120 ↗InjuryNov 10, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND SKIN IRRITATION ON THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED) AND SUBSEQUENTLY, WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2021, IN ORDER TO REMOVE THE ABUTMENT. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).
Patient problems: Skin Inflammation/ Irritation; Unspecified Infection
MAUDE report 12785114 ↗InjuryNov 10, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AND SKIN IRRITATION ON THE ABUTMENT SITE (SPECIFIC DATE NOT REPORTED) AND SUBSEQUENTLY, WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2021, IN ORDER TO REMOVE THE ABUTMENT. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED).
Patient problems: Skin Inflammation/ Irritation; Unspecified Infection
MAUDE report 12785113 ↗
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 93100Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL6 reports
- Vistafix 92996Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL6 reports
- Vistafix 92995Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL4 reports
- Fixture ST 3mm 90438Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL2 reports
- Vistafix 92994Cochlear 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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