Brånemark System® 32115Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III Groovy NP 3.3x11.5mm · Class 2 · Implant
All models of Brånemark System (141)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Brånemark System implant has 80 adverse event reports: all 80 are injuries, with no deaths or malfunctions. Reports mostly describe loss of osseointegration or failure to osseointegrate, sometimes with infection or pain, plus 2 fractures. 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
- 80
- Deaths reported
- 0
- Injuries reported
- 80
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 07332747000870), received between Oct 29, 2021 and Jun 10, 2026 — classified as 80 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (62 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 Osseointegration62
- Failure to Osseointegrate16
- Fracture2
Patient problems
- Failure of Implant62
- Unspecified Infection18
- Pain16
- No Clinical Signs, Symptoms or Conditions6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464074 ↗InjuryJun 10, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464069 ↗InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24355715 ↗InjuryFeb 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24355689 ↗InjuryJan 6, 2026Loss of Osseointegration
InjuryJan 6, 2026Loss of Osseointegration
InjuryDec 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23409865 ↗InjuryOct 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23409852 ↗InjurySep 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23046736 ↗InjurySep 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23046735 ↗InjurySep 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 6, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 5, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 18, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 18, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 18, 2024Loss of Osseointegration; Loss of Osseointegration
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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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