Brånemark System® 32122Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III Groovy RP 3.75x13mm · 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 has 390 reports in the FDA database, all of them describing injuries, and no deaths. Most reports describe the implant losing its bond with the jawbone (loss of osseointegration), after which the implant fails. Reports also mention infection, pain, and numbness. 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
- 396
- Deaths reported
- 0
- Injuries reported
- 396
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 396 adverse event reports that list this exact device (DI 07332747000931), received between Sep 12, 2019 and Sep 14, 2026 — classified as 396 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (352 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 Osseointegration352
- Failure to Osseointegrate16
- Fracture16
- Osseointegration Problem10
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Failure of Implant306
- Unspecified Infection112
- Pain74
- Numbness38
- No Clinical Signs, Symptoms or Conditions32
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available16
- Abscess12
- Sinus Perforation2
Recent adverse event reports
The 25 most recent of 396 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50749152 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50749150 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50749147 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50749144 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742996 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742993 ↗InjuryJul 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848209 ↗InjuryJul 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848205 ↗InjuryJun 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25554922 ↗InjuryJun 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25554896 ↗InjuryJun 12, 2026Loss of Osseointegration
InjuryJun 12, 2026Loss of Osseointegration
InjuryJun 12, 2026Loss of Osseointegration
InjuryMay 26, 2026Loss of Osseointegration
InjuryMay 26, 2026Loss of Osseointegration
InjuryMay 26, 2026Loss of Osseointegration
InjuryMay 26, 2026Loss of Osseointegration
InjuryApr 30, 2026Loss of Osseointegration
InjuryApr 30, 2026Loss of Osseointegration
InjuryMar 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 24708219 ↗InjuryMar 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 24708200 ↗InjuryMar 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 24708199 ↗InjuryMar 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 24708197 ↗InjuryMar 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 24541483 ↗InjuryMar 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 24541298 ↗
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- 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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