Brånemark System® 32117Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III Groovy NP 3.3x15mm · 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 dental implant is a screw-shaped root implant used as an anchor for replacement teeth. The 48 adverse event reports mostly describe the implant losing its bond with the surrounding jawbone, so the implant fails and has to be removed; a few also mention infection or pain. All48 reports involve injuries, with no deaths, and no recalls name this device. Reports fell from 16 in the previous 12 months to 4 in the latest 12 months.
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
- 48
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07332747000894), received between Nov 6, 2021 and Apr 18, 2026 — classified as 48 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (44 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 Osseointegration44
- Failure to Osseointegrate2
- Osseointegration Problem2
Patient problems
- Failure of Implant40
- Unspecified Infection12
- Pain2
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2026Loss of Osseointegration
InjuryApr 18, 2026Loss of Osseointegration
InjuryDec 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 23, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 23, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryApr 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21769241 ↗InjuryApr 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21769235 ↗InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 2, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20354137 ↗InjuryOct 2, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20353971 ↗InjuryJul 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19765593 ↗InjuryJul 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19765590 ↗InjuryJul 17, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19765586 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page