Brånemark System® 32137Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III Groovy WP 5.0x15mm · 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 root-form implant placed in the jaw to support dental work. The 26 reports describe implants loosening or not staying bonded to bone, often with infection, and mention no deaths and 26 injuries. No recalls name this device, with 6 reports in the last 12 months compared with 20 in the prior 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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07332747001099), received between Nov 18, 2024 and Apr 11, 2026 — classified as 26 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (26 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 Osseointegration26
Patient problems
- Unspecified Infection14
- Failure of Implant12
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryApr 11, 2026Loss of Osseointegration
InjuryApr 11, 2026Loss of Osseointegration
InjuryMar 12, 2026Loss of Osseointegration
InjuryMar 11, 2026Loss of Osseointegration
InjuryNov 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 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
InjuryDec 6, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 6, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 5, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 5, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 19, 2024Loss of Osseointegration; Loss of Osseointegration
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.
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