Brånemark System® 28866 (UDI 07332747025200)Recalls & reported problems
Nobel Biocare AB · Zygoma Implant RP 45mm · Class 2 · Implant
All models of Brånemark System (141)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07332747025200), received between Nov 21, 2019 and Mar 8, 2022 — classified as 5 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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
- Failure to Osseointegrate2
- Fracture2
- Loss of Osseointegration1
Patient problems
- Failure of Implant5
- Numbness1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13689025 ↗InjuryMar 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13688806 ↗InjuryDec 3, 2021Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 12927514 ↗InjuryDec 3, 2021Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 12927428 ↗InjuryNov 21, 2019Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Numbness; Pain; Unspecified Infection
MAUDE report 9352462 ↗
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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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