Brånemark System® 32118Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III Shorty RP Ø3.75 · 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 dental implant has 144 FDA adverse event reports, with no deaths and 144 injuries. Most describe the implant losing its bond with the jawbone or failing to fuse with it, and patients were most often reported with implant failure. Some mention infection or pain. 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
- 146
- Deaths reported
- 0
- Injuries reported
- 146
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 07332747000979), received between Sep 11, 2019 and Sep 17, 2026 — classified as 146 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (122 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 Osseointegration122
- Failure to Osseointegrate22
- Osseointegration Problem2
Patient problems
- Failure of Implant116
- Unspecified Infection24
- Pain18
- No Clinical Signs, Symptoms or Conditions14
- Inflammation4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Fistula2
- Numbness2
Recent adverse event reports
The 25 most recent of 146 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811372 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811370 ↗InjuryJun 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525466 ↗InjuryJun 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525461 ↗InjuryJun 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525450 ↗InjuryJun 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525432 ↗InjuryMay 13, 2026Loss of Osseointegration
InjuryMay 13, 2026Loss of Osseointegration
InjuryMay 13, 2026Loss of Osseointegration
InjuryMay 13, 2026Loss of Osseointegration
InjuryFeb 18, 2026Loss of Osseointegration
InjuryFeb 18, 2026Loss of Osseointegration
InjuryFeb 3, 2026Loss of Osseointegration
InjuryFeb 3, 2026Loss of Osseointegration
InjuryJan 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24073985 ↗InjuryJan 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24073973 ↗InjuryNov 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23624156 ↗InjuryNov 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23622731 ↗InjurySep 2, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 2, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22757546 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22757543 ↗InjuryJul 23, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 23, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22423676 ↗
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- 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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