Brånemark System® 32128Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III Groovy RP 4.0x11.5mm · Class 2 · Implant
All models of Brånemark System (141)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Nobel Biocare Brånemark System dental implant. Its 257 reports mostly describe implants that did not bond properly with the bone, leading to implant failure, pain and infection. There were no deaths and 256 injuries, and reports fell to 30 in the last 12 months from 48 in the 12 months before. 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
- 259
- Deaths reported
- 0
- Injuries reported
- 258
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 259 adverse event reports that list this exact device (DI 07332747001013), received between Sep 11, 2019 and Sep 30, 2026 — classified as 258 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (206 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration206
- Failure to Osseointegrate25
- Osseointegration Problem14
- Fracture10
- Adverse Event Without Identified Device or Use Problem2
- Malposition of Device2
Patient problems
- Failure of Implant191
- Pain69
- Unspecified Infection52
- No Clinical Signs, Symptoms or Conditions36
- Abscess6
- Numbness6
- Fistula4
Recent adverse event reports
The 25 most recent of 259 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953591 ↗InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953589 ↗InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25495934 ↗InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25495931 ↗InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25384857 ↗InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25384851 ↗InjuryMay 28, 2026Loss of Osseointegration
InjuryMay 28, 2026Loss of Osseointegration
InjuryMay 15, 2026Loss of Osseointegration
InjuryMay 15, 2026Loss of Osseointegration
InjuryApr 30, 2026Loss of Osseointegration
InjuryApr 30, 2026Loss of Osseointegration
InjuryMar 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24632837 ↗InjuryMar 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24632833 ↗InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
InjuryJan 28, 2026Loss of Osseointegration
InjuryJan 28, 2026Loss of Osseointegration
InjuryDec 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23784877 ↗InjuryDec 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23784869 ↗InjuryDec 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23784851 ↗InjuryDec 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23784848 ↗InjuryDec 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 2, 2025Loss 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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