NobelActive® 34128 (UDI 07332747010619)Recalls & reported problems
Nobel Biocare AB · NobelActive® Internal NP 3.5x15mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelActive dental implant is placed in the jawbone to support a replacement tooth. Of its 1,113 reports, 1,103 describe injuries and 10 describe malfunctions, with no deaths. Most reports describe implants that failed to fuse with the bone or later lost that connection, and some mention pain and infection. 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
- 1,119
- Deaths reported
- 0
- Injuries reported
- 1,109
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,119 adverse event reports that list this exact device (DI 07332747010619), received between Jun 22, 2019 and Sep 29, 2026 — classified as 1,109 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (526 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 Osseointegration526
- Failure to Osseointegrate432
- Fracture82
- Osseointegration Problem58
- Adverse Event Without Identified Device or Use Problem12
- Material Deformation5
- Migration2
- Premature Separation2
Patient problems
- Failure of Implant985
- Pain207
- Unspecified Infection148
- No Clinical Signs, Symptoms or Conditions103
- Numbness19
- Implant Pain10
- Abscess7
- Fistula6
Recent adverse event reports
The 25 most recent of 1,119 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939894 ↗InjurySep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939893 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743772 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743771 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743766 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743764 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50268218 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266963 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266773 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50264982 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229103 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229102 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229088 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229084 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215700 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215698 ↗InjuryAug 8, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187992 ↗InjuryAug 8, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187991 ↗InjuryAug 7, 2026Loss of Osseointegration
InjuryAug 7, 2026Loss of Osseointegration
InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166631 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166630 ↗InjuryAug 3, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110928 ↗InjuryAug 3, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110926 ↗InjuryJun 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25628717 ↗
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.