NobelSpeedy® 32197Recalls & reported problems
Nobel Biocare AB · NOBELSPEEDY Replace NP 3.5x11.5mm · Class 2 · Implant
All models of NobelSpeedy (88)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelSpeedy dental implant is placed in the jawbone. Its 105 reports, all injury reports, mostly describe the implant failing to fuse with the bone, with patients also reporting implant failure, pain and some infections. There were no deaths, and no recalls name this device. Reports dropped to 7 in the last 12 months from 22 in the previous 12 months.
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
- 104
- Deaths reported
- 0
- Injuries reported
- 104
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 07332747001662), received between Nov 4, 2021 and Aug 27, 2026 — classified as 104 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (88 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 Osseointegration88
- Failure to Osseointegrate12
- Insufficient Device Problem Information2
- Material Deformation2
Patient problems
- Failure of Implant88
- No Clinical Signs, Symptoms or Conditions10
- Pain6
- Unspecified Infection4
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486288 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486287 ↗InjuryApr 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24770969 ↗InjuryApr 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24770968 ↗InjuryJan 22, 2026Loss of Osseointegration
InjuryJan 22, 2026Loss of Osseointegration
InjurySep 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22652264 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22652174 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22652150 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22652145 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22598069 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22597822 ↗InjuryFeb 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 5, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 5, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 19, 2024Loss 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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