Brånemark System® 28916 (UDI 07332747001204)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III TiU RP 3.75x15mm · Class 2 · Implant
All models of Brånemark System (141)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Brånemark System dental implant has 374 reports, all of them injury reports, and no deaths. Most describe the implant losing its bond with the jawbone, with some mentioning pain, infection, fractures or numbness. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 374
- Deaths reported
- 0
- Injuries reported
- 374
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 374 adverse event reports that list this exact device (DI 07332747001204), received between Aug 17, 2017 and Jul 29, 2026 — classified as 374 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (280 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration280
- Failure to Osseointegrate54
- Osseointegration Problem25
- Fracture12
- Insufficient Device Problem Information2
- Break1
Patient problems
- Failure of Implant362
- Pain106
- Unspecified Infection94
- Numbness25
- No Clinical Signs, Symptoms or Conditions4
- Implant Pain2
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 374 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50075926 ↗InjuryJul 29, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50075924 ↗InjuryApr 29, 2026Loss of Osseointegration
InjuryApr 29, 2026Loss of Osseointegration
InjurySep 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22427526 ↗InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22427514 ↗InjuryJul 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 6, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20625557 ↗InjuryNov 6, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20625314 ↗InjuryJun 19, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19569951 ↗InjuryJun 19, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19569931 ↗InjuryJun 19, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19569866 ↗InjuryJun 19, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19569864 ↗InjuryJun 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19472063 ↗InjuryJun 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19471583 ↗InjuryMay 15, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 19324526 ↗InjuryMay 15, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 19324490 ↗InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19128701 ↗InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19128699 ↗InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19128698 ↗InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19128683 ↗InjuryApr 9, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19074938 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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