Brånemark System® 28884Recalls & reported problems
Nobel Biocare AB · Brånemark System Mk III RP 3.75x8.5mm · Class 2 · Implant
All models of Brånemark System (141)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07332747004687), received between Sep 15, 2019 and Dec 5, 2025 — classified as 14 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4 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
- Failure to Osseointegrate4
- Loss of Osseointegration4
- Migration4
- Fracture2
Patient problems
- Failure of Implant10
- Abscess4
- Foreign Body In Patient2
- Pain2
- Unspecified Infection2
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Migration; Migration
DEVICE MOVED FROM INTENDED LOCATION. THE MATERIAL NUMBER HAS BEEN UPDATED. THE CORRECTED INFORMATION IS PROVIDED IN THIS FOLLOW UP REPORT.
Patient problems: Abscess
MAUDE report 23734470 ↗InjuryDec 5, 2025Migration; Migration
DEVICE MOVED FROM INTENDED LOCATION. THE MATERIAL NUMBER HAS BEEN UPDATED. THE CORRECTED INFORMATION IS PROVIDED IN THIS FOLLOW UP REPORT.
Patient problems: Abscess
MAUDE report 23734469 ↗InjuryApr 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21769152 ↗InjuryApr 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21769147 ↗InjurySep 17, 2024Migration; Migration
IMPLANT FAILED DUE TO PART MIGRATES.
Patient problems: Abscess; Foreign Body In Patient
MAUDE report 20240101 ↗InjurySep 17, 2024Migration; Migration
IMPLANT FAILED DUE TO PART MIGRATES.
Patient problems: Abscess; Foreign Body In Patient
MAUDE report 20240073 ↗InjuryJun 3, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19453395 ↗InjuryJun 3, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19453329 ↗InjuryJan 26, 2022Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 13360094 ↗InjuryJan 26, 2022Fracture; Fracture
IMPLANT FAILED DUE TO IMPLANT FRACTURE AFTER DELIVERY.
Patient problems: Failure of Implant
MAUDE report 13360050 ↗InjuryOct 29, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12722941 ↗InjuryOct 29, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12722821 ↗InjurySep 15, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9067658 ↗InjurySep 15, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain
MAUDE report 9064000 ↗
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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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