Brånemark System® 28930 (UDI 07332747159639)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III TiU WP 5.0x15mm · Class 2 · Implant
All models of Brånemark System (141)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07332747159639), received between Jul 28, 2022 and Aug 3, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (14 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 Osseointegrate14
- Osseointegration Problem4
- Loss of Osseointegration2
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Failure of Implant8
- Unspecified Infection4
- Pain2
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110713 ↗InjuryAug 3, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110711 ↗InjuryAug 3, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110706 ↗InjuryAug 3, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110705 ↗InjuryApr 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783770 ↗InjuryApr 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782768 ↗InjuryApr 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782764 ↗InjuryApr 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782741 ↗InjuryDec 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22443758 ↗InjuryJul 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22443688 ↗InjuryJul 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19670162 ↗InjuryJul 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19670120 ↗InjuryMay 11, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 16913674 ↗InjuryMay 11, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 16913669 ↗InjuryMay 8, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 16889216 ↗InjuryMay 8, 2023Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 16889185 ↗InjuryJul 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 15125345 ↗InjuryJul 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 15125276 ↗
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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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