NobelActive® 34126 (UDI 07332747010596)Recalls & reported problems
Nobel Biocare AB · NobelActive® Internal NP 3.5x11.5mm · Class 2 · Implant
Quick summary
This NobelActive dental implant is a root-form implant placed in the jawbone. Its 3,321 reports mostly describe the implant failing to fuse with the jawbone, with patients reporting implant failure, pain and infection. The reports include no deaths and 3,303 injuries. No recalls name this device. Reports were lower in the most recent year (147) than in the year before (203).
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
- 3,328
- Deaths reported
- 0
- Injuries reported
- 3,310
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,328 adverse event reports that list this exact device (DI 07332747010596), received between Sep 10, 2019 and Sep 29, 2026 — classified as 3,310 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (1,640 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 Osseointegration1,640
- Failure to Osseointegrate1,195
- Fracture282
- Osseointegration Problem121
- Adverse Event Without Identified Device or Use Problem55
- Insufficient Device Problem Information11
- Material Deformation9
- Migration8
Patient problems
- Failure of Implant3,041
- Pain674
- Unspecified Infection398
- No Clinical Signs, Symptoms or Conditions175
- Numbness75
- Abscess24
- Inflammation18
- Implant Pain14
Recent adverse event reports
The 25 most recent of 3,328 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 50939949 ↗InjurySep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939948 ↗InjurySep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939940 ↗InjurySep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939938 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811834 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811832 ↗InjuryAug 21, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382045 ↗InjuryAug 8, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187867 ↗InjuryAug 8, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187866 ↗InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183512 ↗InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183510 ↗InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183495 ↗InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183491 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167753 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167752 ↗InjuryAug 5, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149174 ↗InjuryAug 5, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149170 ↗InjuryJul 31, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105917 ↗InjuryJul 31, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105915 ↗InjuryJul 1, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683844 ↗InjuryJul 1, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683843 ↗InjuryJun 27, 2026Loss of Osseointegration
InjuryJun 27, 2026Loss of Osseointegration
InjuryJun 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25646525 ↗InjuryJun 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25646511 ↗
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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.