Vistafix 92997Recalls & reported problems
Cochlear Bone Anchored Solutions AB · Cochlear™ Vistafix® VXA300 Abutment 7.5mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 09321502021692), received between Aug 15, 2017 and May 26, 2023 — classified as 8 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
- Appropriate Device Problem Term/Code Not Available2
- Loss of Osseointegration1
- Osseointegration Problem1
Patient problems
- Impaired Healing2
- No Code Available2
- Skin Inflammation/ Irritation2
- Swelling/ Edema2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryNov 12, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A SOFT TISSUE REDUCTION SURGERY UNDER GENERAL ANESTHESIA (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing
MAUDE report 12801631 ↗InjuryNov 12, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A SOFT TISSUE REDUCTION SURGERY UNDER GENERAL ANESTHESIA (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.
Patient problems: Impaired Healing
MAUDE report 12801608 ↗InjuryApr 19, 2018Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION, RE-IMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AS OF THE DATE OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 7445855 ↗InjuryAug 15, 2017Osseointegration Problem; Osseointegration Problem
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION, SUBSEQUENT TO THE PATIENT EXPERIENCING PAIN AND DRAINAGE AT THE AT THE ABUTMENT SITE. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS FOR A PERIOD OF 7 DAYS.
Patient problems: No Code Available
MAUDE report 6793619 ↗
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 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
- 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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