Vistafix 92995Recalls & reported problems
Cochlear Bone Anchored Solutions AB · Cochlear™ Vistafix® VXA300 Abutment 4.5mm · Class 2 · Implant
Data updated Oct 13, 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 09321502021678), received between Jun 23, 2022 and Jun 23, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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.
Most reported problems
Device problems
- Patient Device Interaction Problem4
Patient problems
- Impaired Healing4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2022, IN ORDER TO REMOVE THE ABUTMENT.
Patient problems: Impaired Healing
MAUDE report 14786021 ↗InjuryJun 23, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2022, IN ORDER TO REMOVE THE ABUTMENT.
Patient problems: Impaired Healing
MAUDE report 14786011 ↗InjuryJun 23, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2022, IN ORDER TO REMOVE THE ABUTMENT.
Patient problems: Impaired Healing
MAUDE report 14786001 ↗InjuryJun 23, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2022, IN ORDER TO REMOVE THE ABUTMENT.
Patient problems: Impaired Healing
MAUDE report 14785997 ↗
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 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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