NobelSpeedy® 32194Recalls & reported problems
Nobel Biocare AB · NOBELSPEEDY Replace 6.0 6x15mm · Class 2 · Implant
All models of NobelSpeedy (88)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07332747001631), received between Mar 30, 2022 and Sep 18, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (8 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 Osseointegration8
- Failure to Osseointegrate2
Patient problems
- Failure of Implant6
- No Clinical Signs, Symptoms or Conditions4
- Pain4
- Unspecified Infection2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830369 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830367 ↗InjuryJul 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711677 ↗InjuryJul 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711674 ↗InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 1, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 1, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 15340799 ↗InjurySep 1, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 15340664 ↗InjuryMar 30, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 13955348 ↗InjuryMar 30, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 13955295 ↗
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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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