Brånemark System® 28908 (UDI 07332747159424)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III TiU NP 3.3x13mm · 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 System dental implant is placed in the jawbone to hold a replacement tooth. All 90 reports are coded as injuries, and no deaths are recorded. Reports mostly describe implants that lost or never formed a bond with the jawbone, with some describing infection, pain or numbness. There were 24 reports in the last 12 months, up from 12 in the year before. 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
- 92
- Deaths reported
- 0
- Injuries reported
- 92
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 07332747159424), received between Nov 26, 2021 and Sep 11, 2026 — classified as 92 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (54 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
- Failure to Osseointegrate54
- Loss of Osseointegration32
- Osseointegration Problem4
- Fracture2
Patient problems
- Failure of Implant56
- No Clinical Signs, Symptoms or Conditions28
- Pain10
- Unspecified Infection10
- Numbness2
Recent adverse event reports
The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50742684 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50742668 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229029 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229024 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229017 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229016 ↗InjuryJun 17, 2026Loss of Osseointegration
InjuryJun 17, 2026Loss of Osseointegration
InjuryMay 28, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25324215 ↗InjuryMay 28, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25324211 ↗InjuryMay 28, 2026Loss of Osseointegration
InjuryMay 28, 2026Loss of Osseointegration
InjuryMay 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25309327 ↗InjuryMay 27, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25309322 ↗InjuryApr 21, 2026Failure to Osseointegrate
InjuryApr 21, 2026Failure to Osseointegrate
InjuryApr 9, 2026Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24836492 ↗InjuryApr 9, 2026Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24836486 ↗InjuryMar 31, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748189 ↗InjuryMar 31, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748188 ↗InjuryJan 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24170959 ↗InjuryJan 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24170956 ↗InjuryJan 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24061868 ↗InjuryJan 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24061854 ↗InjuryDec 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23859402 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- 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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