Brånemark System® 28863 (UDI 07332747025170)Recalls & reported problems
Nobel Biocare AB · Zygoma Implant RP 35mm · Class 2 · Implant
All models of Brånemark System (141)
Data updated Oct 16, 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 07332747025170), received between Feb 7, 2022 and May 7, 2024 — classified as 8 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate4
- Loss of Osseointegration4
Patient problems
- Failure of Implant8
- Inflammation2
- Pain2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Inflammation
MAUDE report 19263706 ↗InjuryMay 7, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Inflammation
MAUDE report 19263703 ↗InjuryJun 29, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 14858183 ↗InjuryJun 29, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 14857984 ↗InjuryJun 20, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 14747765 ↗InjuryJun 20, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 14747728 ↗InjuryFeb 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13475766 ↗InjuryFeb 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13475746 ↗
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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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