Brånemark System® 32114Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III Groovy NP 3.3x10mm · Class 2 · Implant
Data updated Oct 13, 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. Of the 160 reports, most describe implants that lost their bond with the jawbone, and a few describe pain, numbness, or infection. The reports include no deaths and 159 injuries. 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
- 160
- Deaths reported
- 0
- Injuries reported
- 159
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 160 adverse event reports that list this exact device (DI 07332747000863), received between Sep 11, 2019 and May 5, 2026 — classified as 159 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (142 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 Osseointegration142
- Failure to Osseointegrate12
- Adverse Event Without Identified Device or Use Problem2
- Fracture2
- Osseointegration Problem2
Patient problems
- Failure of Implant128
- Pain24
- Unspecified Infection18
- No Clinical Signs, Symptoms or Conditions16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Numbness4
- Abscess2
- Inflammation2
Recent adverse event reports
The 25 most recent of 160 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25087786 ↗InjuryMay 5, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25087759 ↗InjuryApr 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25023487 ↗InjuryApr 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25023426 ↗InjuryMar 10, 2026Loss of Osseointegration
InjuryMar 10, 2026Loss of Osseointegration
InjuryFeb 18, 2026Loss of Osseointegration
InjuryFeb 18, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24358213 ↗InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24358212 ↗InjuryJan 21, 2026Loss of Osseointegration
InjuryJan 21, 2026Loss of Osseointegration
InjuryJan 6, 2026Loss of Osseointegration
InjuryJan 6, 2026Loss of Osseointegration
InjuryDec 9, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23762968 ↗InjuryDec 9, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23762965 ↗InjuryNov 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23624158 ↗InjuryNov 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23622764 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22757435 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22757414 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22444290 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22444289 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22444281 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22444279 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22444274 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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