Brånemark System® 28867 (UDI 07332747025217)Recalls & reported problems
Nobel Biocare AB · Zygoma Implant RP 47.5mm · Class 2 · Implant
All models of Brånemark System (141)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07332747025217), received between Sep 12, 2019 and Jan 11, 2024 — classified as 10 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
- Osseointegration Problem2
Patient problems
- Failure of Implant10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryJan 11, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18498029 ↗InjuryJan 11, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18497870 ↗InjuryNov 16, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15809783 ↗InjuryNov 16, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15808653 ↗InjuryMay 24, 2022Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 14491231 ↗InjuryMay 24, 2022Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 14491219 ↗InjuryMar 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13689033 ↗InjuryMar 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13688821 ↗InjurySep 13, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 9018757 ↗InjurySep 12, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 9001257 ↗
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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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