NobelSpeedy® 32202Recalls & reported problems
Nobel Biocare AB · NOBELSPEEDY Replace RP 4x13mm · 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 implant is a root-form implant placed into the bone. Its 403 adverse event reports often describe the implant losing its bond with the bone, and some describe pain, infection and numbness. The reports include no deaths and 403 injuries. 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
- 403
- Deaths reported
- 0
- Injuries reported
- 403
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 403 adverse event reports that list this exact device (DI 07332747001716), received between Sep 12, 2019 and Aug 11, 2026 — classified as 403 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (339 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 Osseointegration339
- Failure to Osseointegrate28
- Fracture20
- Osseointegration Problem6
- Adverse Event Without Identified Device or Use Problem2
- Defective Device2
- Device Damaged by Another Device2
- Insufficient Device Problem Information2
Patient problems
- Failure of Implant328
- Pain88
- Unspecified Infection68
- No Clinical Signs, Symptoms or Conditions45
- Numbness10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Abscess6
- Sinus Perforation4
Recent adverse event reports
The 25 most recent of 403 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Loss of Osseointegration
InjuryAug 11, 2026Loss of Osseointegration
InjuryJul 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25805293 ↗InjuryJul 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25805286 ↗InjuryJul 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25805148 ↗InjuryJul 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25805147 ↗InjuryJun 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25571042 ↗InjuryJun 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540266 ↗InjuryJun 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540254 ↗InjuryMay 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25262552 ↗InjuryMay 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25262439 ↗InjuryMay 14, 2026Loss of Osseointegration
InjuryMay 14, 2026Loss of Osseointegration
InjuryApr 30, 2026Loss of Osseointegration
InjuryApr 30, 2026Loss of Osseointegration
InjuryApr 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917325 ↗InjuryApr 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917322 ↗InjuryMar 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24707481 ↗InjuryMar 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24707477 ↗InjuryFeb 17, 2026Loss of Osseointegration
InjuryFeb 17, 2026Loss of Osseointegration
InjuryFeb 17, 2026Loss of Osseointegration
InjuryFeb 17, 2026Loss of Osseointegration
InjuryFeb 17, 2026Loss of Osseointegration
InjuryFeb 17, 2026Loss of Osseointegration
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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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