NobelSpeedy® 32198Recalls & reported problems
Nobel Biocare AB · NOBELSPEEDY Replace NP 3.5x13mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelSpeedy dental implant is a root-form implant placed into bone. Its 152 adverse event reports are all listed as injuries, with no deaths, and most describe implants losing their bond with the bone, along with infections, pain and occasional 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
- 150
- Deaths reported
- 0
- Injuries reported
- 150
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 07332747001679), received between Nov 4, 2021 and Jan 17, 2026 — classified as 150 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (128 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration128
- Fracture10
- Failure to Osseointegrate6
- Adverse Event Without Identified Device or Use Problem2
- Migration2
- Osseointegration Problem2
Patient problems
- Failure of Implant126
- Pain30
- Unspecified Infection30
- No Clinical Signs, Symptoms or Conditions10
- Abscess4
- Numbness4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Fistula2
Recent adverse event reports
The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24106382 ↗InjuryJan 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24106380 ↗InjuryJan 13, 2026Loss of Osseointegration
InjuryJan 13, 2026Loss of Osseointegration
InjuryNov 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23599771 ↗InjuryNov 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23599770 ↗InjuryNov 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23527978 ↗InjuryNov 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23527864 ↗InjuryOct 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23408721 ↗InjuryOct 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23408701 ↗InjurySep 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22947051 ↗InjurySep 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22946862 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22605546 ↗InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22604776 ↗InjuryJul 10, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 10, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 19, 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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