NobelSpeedy® 33125 (UDI 07332747001464)Recalls & reported problems
Nobel Biocare AB · NobelSpeedy® Groovy NP 3.3x13mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelSpeedy implant is placed in bone. Most of the 303 reports describe the implant failing to bond with the bone, and some mention fractures, pain, or infection. The reports include 303 injuries and no deaths, and 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
- 303
- Deaths reported
- 0
- Injuries reported
- 303
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 303 adverse event reports that list this exact device (DI 07332747001464), received between Sep 10, 2019 and Jun 26, 2026 — classified as 303 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (193 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 Osseointegration193
- Failure to Osseointegrate73
- Osseointegration Problem13
- Fracture12
- Adverse Event Without Identified Device or Use Problem10
- Separation Failure2
Patient problems
- Failure of Implant287
- Pain72
- Unspecified Infection35
- Abscess10
- No Clinical Signs, Symptoms or Conditions10
- Numbness9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Bone Fracture(s)4
Recent adverse event reports
The 25 most recent of 303 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25643222 ↗InjuryJun 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25643221 ↗InjuryMay 28, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25324362 ↗InjuryMay 28, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25324360 ↗InjuryApr 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24905575 ↗InjuryApr 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24905548 ↗InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810172 ↗InjuryApr 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810081 ↗InjuryJan 15, 2026Failure to Osseointegrate
InjuryJan 15, 2026Failure to Osseointegrate
InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 23420161 ↗InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 23420159 ↗InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 23420153 ↗InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 23420150 ↗InjurySep 17, 2025Osseointegration Problem; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23077968 ↗InjurySep 17, 2025Osseointegration Problem; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23077940 ↗InjuryMar 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 21734695 ↗InjuryMar 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 21734694 ↗InjuryMar 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 21734692 ↗InjuryMar 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 21734691 ↗InjuryDec 27, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 27, 2024Loss of Osseointegration; Loss of Osseointegration
InjurySep 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 20206949 ↗InjurySep 12, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 20206818 ↗InjuryMay 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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 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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