Vistafix 93101Recalls & reported problems
Cochlear Bone Anchored Solutions AB · Cochlear™ Vistafix® VXI300 Implant 4mm · Class 2 · Implant
All models of Vistafix (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 09321502021722), received between Jan 24, 2018 and May 2, 2023 — classified as 14 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Loss of Osseointegration7
- Patient Device Interaction Problem4
- Appropriate Device Problem Term/Code Not Available3
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Inadequate Osseointegration4
- Hematoma2
- Host-Tissue Reaction1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryOct 5, 2021Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN IMPLANT AND ABUTMENT LOSS. REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AS OF THE DATE OF THIS REPORT.
Patient problems: Inadequate Osseointegration
MAUDE report 12574804 ↗InjurySep 8, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, THE PATIENT HAD HEMATOMAS BEHIND THE TEMPORALIS FLAP AND SUBSEQUENTLY, UNDERWENT DRAINAGE OF HEMATOMAS AND TISSUE REVISION USING A BIOPSY PUNCH (SPECIFIC DATE NOT REPORTED).
Patient problems: Hematoma
MAUDE report 12437343 ↗InjurySep 8, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TISSUE REDUCTION SURGERY ON (B)(6) 2021.
Patient problems: Hematoma
MAUDE report 12437341 ↗InjuryApr 7, 2021Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN IMPLANT LOSS. THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2021.
Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 11625858 ↗InjuryDec 29, 2020Loss of Osseointegration; Loss of Osseointegration
PER THE SURGEON, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION ON (B)(6) 2020, RESULTING IN FIXTURE LOSS. THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE AND DURATION NOT REPORTED). REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11092685 ↗InjuryDec 29, 2020Loss of Osseointegration; Loss of Osseointegration
PER THE SURGEON, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION ON (B)(6) 2020, RESULTING IN FIXTURE LOSS. THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE AND DURATION NOT REPORTED). REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11092684 ↗InjuryNov 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020, IN ORDER TO REMOVE OVERGROWN TISSUE AND CHANGE THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10881840 ↗InjuryNov 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020, IN ORDER TO REMOVE OVERGROWN TISSUE AND CHANGE THE ABUTMENT. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10881839 ↗InjuryNov 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020, IN ORDER TO REMOVE OVERGROWN TISSUE. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10881836 ↗InjuryNov 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2020, IN ORDER TO REMOVE OVERGROWN TISSUE. THE IMPLANTED DEVICE REMAINS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10881835 ↗InjurySep 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN OVERGROWTH AT ABUTMENT SITES AND SUBSEQUENTLY UNDERWENT SKIN REVISION ON (B)(6) 2018.
Patient problems: Host-Tissue Reaction
MAUDE report 7917352 ↗InjuryJan 24, 2018Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION SUBSEQUENT TO THE PATIENT EXPERIENCING PAIN AND SECRETION AT THE ABUTMENT SITE. THE DEVICE WAS EXPLANTED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS.
Patient problems: Pain
MAUDE report 7214567 ↗
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 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
- 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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