Brånemark System® 28911 (UDI 07332747159448)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III TiU RP 3.75x7mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Brånemark System dental implant is placed in the jawbone to support a replacement tooth. Its 191 reports mostly describe implants that failed to bond with the bone, lost that bond later, or could not be held firmly enough when placed. Some reports mention infection, pain or numbness. There are 188 injury reports and no deaths. No recalls name this device. Reports fell from 44 in the year before to 21 in the latest year.
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
- 193
- Deaths reported
- 0
- Injuries reported
- 190
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 193 adverse event reports that list this exact device (DI 07332747159448), received between Nov 4, 2021 and Sep 9, 2026 — classified as 190 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (107 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
- Failure to Osseointegrate107
- Loss of Osseointegration72
- Adverse Event Without Identified Device or Use Problem6
- Osseointegration Problem6
- Difficult to Remove2
Patient problems
- Failure of Implant138
- No Clinical Signs, Symptoms or Conditions24
- Unspecified Infection19
- Pain14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Numbness8
- Inflammation4
- Abscess2
Recent adverse event reports
The 25 most recent of 193 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700614 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700612 ↗InjuryJul 8, 2026Loss of Osseointegration
InjuryJul 8, 2026Loss of Osseointegration
InjuryJun 23, 2026Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601815 ↗InjuryJun 23, 2026Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601813 ↗InjuryJun 11, 2026Loss of Osseointegration
InjuryJun 11, 2026Loss of Osseointegration
InjuryJun 9, 2026Failure to Osseointegrate
InjuryJun 9, 2026Failure to Osseointegrate
InjuryJun 4, 2026Failure to Osseointegrate
InjuryMay 8, 2026Loss of Osseointegration
InjuryMay 8, 2026Loss of Osseointegration
InjuryApr 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24900472 ↗InjuryApr 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24900470 ↗InjuryMar 26, 2026Failure to Osseointegrate
InjuryMar 26, 2026Failure to Osseointegrate
InjuryFeb 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24230458 ↗InjuryFeb 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24230437 ↗InjuryDec 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23709529 ↗InjuryDec 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23709528 ↗InjurySep 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23090697 ↗InjurySep 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23090684 ↗
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 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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