Fixture ST 3mm 90438Recalls & reported problems
Cochlear Bone Anchored Solutions AB · Fixture ST 3mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09321502014335), received between Aug 6, 2020 and Aug 6, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 Osseointegration2
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2020Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AS OF THE DATE OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 10377186 ↗InjuryAug 6, 2020Loss of Osseointegration; Loss of Osseointegration
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AS OF THE DATE OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 10377182 ↗
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
- Vistafix 92995Cochlear Bone Anchored Solutions AB · PROSTHESIS, NOSE, INTERNAL4 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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