NobelActive® 34139 (UDI 07332747010688)Recalls & reported problems
Nobel Biocare AB · NobelActive® Internal RP 5.0x13mm · Class 2 · Implant
All models of NobelActive (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelActive root-form implant is placed in bone. Most of the 1,356 reports describe the implant losing or failing to bond with the bone, and some mention pain or infection. The reports include no deaths and 1,345 injuries. Reports fell from 110 in the prior 12 months to 60 in the latest 12 months. 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
- 1,365
- Deaths reported
- 0
- Injuries reported
- 1,354
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,365 adverse event reports that list this exact device (DI 07332747010688), received between Sep 10, 2019 and Sep 15, 2026 — classified as 1,354 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (684 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 Osseointegration684
- Failure to Osseointegrate478
- Fracture106
- Osseointegration Problem59
- Adverse Event Without Identified Device or Use Problem25
- Patient Device Interaction Problem6
- Insufficient Device Problem Information4
- Mechanical Problem2
Patient problems
- Failure of Implant1,226
- Pain213
- Unspecified Infection178
- No Clinical Signs, Symptoms or Conditions91
- Numbness23
- Implant Pain6
- Inflammation6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
Recent adverse event reports
The 25 most recent of 1,365 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781211 ↗InjurySep 15, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781207 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749114 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749107 ↗InjuryAug 22, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50392615 ↗InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183507 ↗InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183506 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50014164 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50014163 ↗InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848814 ↗InjuryJul 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848813 ↗InjuryJul 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25698649 ↗InjuryJul 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25698631 ↗InjuryJun 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538922 ↗InjuryJun 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538920 ↗InjuryJun 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538910 ↗InjuryJun 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538907 ↗InjuryJun 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25493135 ↗InjuryJun 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25493134 ↗
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- 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 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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