Brånemark System® 32133Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III Groovy WP 5.0x8.5mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare Brånemark dental implant is placed in the jawbone to support a replacement tooth. Most reports describe implants that lost their bond with the bone, and some describe infection, pain or abscesses. The 156 reports include no deaths and 156 injuries. No recalls name this device, and reports fell from 24 in the prior 12 months to 8 in the latest 12 months.
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
- 156
- Deaths reported
- 0
- Injuries reported
- 156
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 156 adverse event reports that list this exact device (DI 07332747001051), received between Nov 24, 2021 and Jun 17, 2026 — classified as 156 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (134 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 Osseointegration134
- Failure to Osseointegrate12
- Osseointegration Problem6
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Failure of Implant134
- Unspecified Infection26
- Pain24
- No Clinical Signs, Symptoms or Conditions10
- Abscess6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Fistula2
- Inflammation2
Recent adverse event reports
The 25 most recent of 156 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540212 ↗InjuryJun 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25539666 ↗InjuryApr 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974031 ↗InjuryApr 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974016 ↗InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
InjuryDec 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929206 ↗InjuryDec 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23929199 ↗InjuryOct 23, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373977 ↗InjuryOct 23, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23373955 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22957900 ↗InjurySep 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22957896 ↗InjuryAug 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22514700 ↗InjuryJul 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22514693 ↗InjuryMar 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21726221 ↗InjuryMar 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21726216 ↗InjuryMar 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21519891 ↗
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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