Brånemark System® 28939Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk IV TiU WP 5.0x7mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Brånemark System Mk IV root-form implant has 40 adverse event reports that name its identifier, describing implant failure from loss of osseointegration, sometimes with infection or pain. The reports mention 40 injuries and no deaths. 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
- 42
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07332747013337), received between Nov 10, 2021 and Sep 14, 2026 — classified as 42 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (28 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration28
- Failure to Osseointegrate8
- Insufficient Device Problem Information4
- Osseointegration Problem2
Patient problems
- Failure of Implant30
- Unspecified Infection8
- Pain6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764845 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764844 ↗InjuryApr 21, 2026Loss of Osseointegration
InjuryApr 21, 2026Loss of Osseointegration
InjuryJan 6, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23983931 ↗InjuryJan 6, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23983928 ↗InjurySep 9, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 23010874 ↗InjurySep 9, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 23010872 ↗InjurySep 16, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20231530 ↗InjurySep 16, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20231305 ↗InjuryMar 28, 2024Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 18999773 ↗InjuryMar 28, 2024Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 18997651 ↗InjuryMar 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18945006 ↗InjuryMar 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18945004 ↗InjuryAug 31, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17665412 ↗InjuryAug 31, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 17665409 ↗InjuryOct 27, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15684641 ↗InjuryOct 27, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15684612 ↗InjuryOct 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 15566020 ↗InjuryOct 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 15564991 ↗InjurySep 13, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15413115 ↗InjurySep 13, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15413113 ↗InjuryAug 9, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15194298 ↗InjuryAug 9, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15194264 ↗InjuryAug 1, 2022Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15140921 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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