Brånemark System® 28927 (UDI 07332747001310)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III TiU WP 5.0x10mm · Class 2 · Implant
All models of Brånemark System (141)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare Brånemark System implant is a root-form implant placed in the jawbone to support a replacement tooth. Its 377 reports mostly describe implants that lost their hold in the jawbone, and some mention pain, infection or numbness. The reports include 377 injuries and no deaths. Reports fell from 8 in the previous 12 months to 0 in the last 12 months. 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
- 378
- Deaths reported
- 0
- Injuries reported
- 378
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 378 adverse event reports that list this exact device (DI 07332747001310), received between Sep 10, 2019 and Aug 21, 2026 — classified as 378 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (282 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
- Loss of Osseointegration282
- Failure to Osseointegrate51
- Osseointegration Problem39
- Fracture8
Patient problems
- Failure of Implant366
- Pain108
- Unspecified Infection42
- Numbness22
- No Clinical Signs, Symptoms or Conditions4
- Abscess2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Inadequate Osseointegration1
Recent adverse event reports
The 25 most recent of 378 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50381433 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23078960 ↗InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23078953 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 29, 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 22427468 ↗InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22427464 ↗InjuryOct 8, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20401460 ↗InjuryOct 8, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20401375 ↗InjuryJun 18, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19561582 ↗InjuryJun 18, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19561532 ↗InjuryJun 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19552873 ↗InjuryJun 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19552872 ↗InjuryJun 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19552838 ↗InjuryJun 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19552785 ↗InjuryJun 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19487303 ↗InjuryJun 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19486928 ↗InjuryMay 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19401932 ↗InjuryMay 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19401931 ↗InjuryMay 23, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19386791 ↗InjuryMay 23, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19386789 ↗InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19366759 ↗InjuryMay 21, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19366569 ↗
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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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