Brånemark System® 28916 (UDI 07332747159493)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III TiU RP 3.75x15mm · 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 implant is a titanium screw placed in the jawbone to hold a replacement tooth. Its 240 reports mostly describe the implant losing or failing to fuse with the jawbone, and some mention infection. The reports include 240 injuries and no deaths, and they fell from 110 in the prior 12 months to 48 in the last 12 months. 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
- 240
- Deaths reported
- 0
- Injuries reported
- 240
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 240 adverse event reports that list this exact device (DI 07332747159493), received between Nov 19, 2021 and Aug 18, 2026 — classified as 240 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (154 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 Osseointegration154
- Failure to Osseointegrate58
- Osseointegration Problem12
- Fracture8
- Adverse Event Without Identified Device or Use Problem4
- Migration2
- Premature Separation2
Patient problems
- Failure of Implant134
- Unspecified Infection76
- No Clinical Signs, Symptoms or Conditions45
- Pain14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- Numbness6
- Inflammation4
- Fistula2
Recent adverse event reports
The 25 most recent of 240 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310004 ↗InjuryAug 18, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310003 ↗InjuryJul 30, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50093218 ↗InjuryJul 30, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50092201 ↗InjuryJul 27, 2026Failure to Osseointegrate
InjuryJul 27, 2026Failure to Osseointegrate
InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 6, 2026Loss of Osseointegration
InjuryJul 6, 2026Loss of Osseointegration
InjuryJul 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711955 ↗InjuryJul 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711949 ↗InjuryJul 2, 2026Loss of Osseointegration
InjuryJul 2, 2026Loss of Osseointegration
InjuryApr 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917387 ↗InjuryApr 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917386 ↗InjuryApr 14, 2026Loss of Osseointegration
InjuryApr 14, 2026Loss of Osseointegration
InjuryApr 14, 2026Loss of Osseointegration
InjuryApr 14, 2026Loss of Osseointegration
InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809659 ↗InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809648 ↗InjuryMar 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24692285 ↗InjuryMar 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24692283 ↗InjuryMar 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24658786 ↗
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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 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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