Brånemark System® 28920 (UDI 07332747001242)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III TiU RP 4.0x10mm · Class 2 · Implant
All models of Brånemark System (141)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Brånemark System dental implant is set into the jawbone to hold a replacement tooth. Most of its 448 reports describe implants that lost their bond with the jawbone or never formed one, and some mention pain, infection or numbness. All 448 reports are listed as injuries, no deaths were reported, and 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
- 448
- Deaths reported
- 0
- Injuries reported
- 448
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 448 adverse event reports that list this exact device (DI 07332747001242), received between Sep 11, 2019 and Jun 17, 2026 — classified as 448 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (324 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 Osseointegration324
- Failure to Osseointegrate87
- Osseointegration Problem23
- Adverse Event Without Identified Device or Use Problem4
- Fracture4
- Mechanical Problem4
- Malposition of Device2
- Physical Resistance/Sticking2
Patient problems
- Failure of Implant424
- Pain112
- Unspecified Infection57
- Numbness24
- No Clinical Signs, Symptoms or Conditions6
- Abscess2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Fistula2
Recent adverse event reports
The 25 most recent of 448 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2026Loss of Osseointegration
InjuryJun 17, 2026Loss of Osseointegration
InjuryJun 3, 2026Loss of Osseointegration
InjuryJun 3, 2026Loss of Osseointegration
InjuryMay 28, 2026Loss of Osseointegration
InjuryMay 28, 2026Loss of Osseointegration
InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809926 ↗InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809920 ↗InjuryFeb 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24448510 ↗InjuryFeb 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24448495 ↗InjuryOct 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 17, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 28, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22625112 ↗InjuryJul 28, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22625110 ↗InjuryJul 28, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22624888 ↗InjuryJul 28, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22624844 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 10, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 9, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 9, 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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