VistafixRecalls & reported problems across all models

We found 7 models of Vistafix by Cochlear Bone Anchored Solutions AB in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Aug 15, 2017 and Feb 19, 2025 — classified as 44 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (22 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. 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

Most reported Vistafix problems

Vistafix models

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

• Vistafix 93101

  PROSTHESIS, NOSE, INTERNAL
  14 reports
• Vistafix 92997

  PROSTHESIS, NOSE, INTERNAL
  8 reports
• Vistafix 92996

  PROSTHESIS, NOSE, INTERNAL
  6 reports
• Vistafix 93100

  PROSTHESIS, NOSE, INTERNAL
  6 reports
• Vistafix 92995

  PROSTHESIS, NOSE, INTERNAL
  4 reports
• Vistafix 92998

  PROSTHESIS, NOSE, INTERNAL
  4 reports
• Vistafix 92994

  PROSTHESIS, NOSE, INTERNAL
  2 reports

Recent Vistafix adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryMay 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  CORRECTION: THE INITIAL MDR SUBMITTED ON MAY 26, 2023, WAS FILED INADVERTENTLY. THERE WAS NO SKIN REVISION.

  Patient problems: Swelling/ Edema

  MAUDE report 17008874 ↗
• InjuryMay 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SWELLING AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT A SKIN REVISION SURGERY (SPECIFIC DATE NOT REPORTED) IN ORDER TO EXPOSE THE ABUTMENT AREA AND TO PLACE A LARGER CAP, HOWEVER, IT WAS UNSUCCESSFUL. THE IMPLANTED DEVICE REMAINS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Swelling/ Edema

  MAUDE report 17008873 ↗
• InjuryMay 2, 2023Loss of Osseointegration; Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16857928 ↗
• InjuryMay 2, 2023Loss of Osseointegration; Loss of Osseointegration

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT. THIS REPORT IS SUBMITTED ON MAY 03, 2023.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16857926 ↗
• InjuryMar 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN IRRITATION AT THE ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE PATIENT ALSO UNDERWENT A SKIN REVISION WITH SILVER NITRATE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16551011 ↗
• InjuryMar 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED SKIN IRRITATION AT THE ABUTMENT SITE AND SUBSEQUENTLY WAS TREATED WITH TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE PATIENT ALSO UNDERWENT A SKIN REVISION WITH SILVER NITRATE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16551010 ↗
• 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 14786026 ↗
• 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 14786022 ↗
• 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 14786016 ↗
• 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 14786014 ↗
• 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 14786010 ↗

Other Cochlear Bone Anchored Solutions AB products

• Baha29 models · 2,358 reports