NobelActive® 34138 (UDI 07332747010671)Recalls & reported problems
Nobel Biocare AB · NobelActive® Internal RP 5.0x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelActive implant is a dental implant placed into the jawbone. Its 2,074 adverse event reports, 2,069 of them injuries, mostly describe the implant losing its bond with the bone or failing to fuse with it, and some mention fractures, pain or infection. The reports include no deaths. 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
- 2,078
- Deaths reported
- 0
- Injuries reported
- 2,073
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,078 adverse event reports that list this exact device (DI 07332747010671), received between Sep 10, 2019 and Sep 11, 2026 — classified as 2,073 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (1,110 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 Osseointegration1,110
- Failure to Osseointegrate649
- Fracture182
- Osseointegration Problem79
- Adverse Event Without Identified Device or Use Problem34
- Patient Device Interaction Problem8
- Insufficient Device Problem Information5
- Migration4
Patient problems
- Failure of Implant1,874
- Pain392
- Unspecified Infection249
- No Clinical Signs, Symptoms or Conditions148
- Numbness36
- Abscess13
- Inflammation10
- Implant Pain8
Recent adverse event reports
The 25 most recent of 2,078 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743795 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743794 ↗InjuryAug 27, 2026Loss of Osseointegration
InjuryAug 27, 2026Loss of Osseointegration
InjuryAug 25, 2026Loss of Osseointegration
InjuryAug 25, 2026Loss of Osseointegration
InjuryAug 25, 2026Loss of Osseointegration
InjuryAug 25, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50441251 ↗InjuryAug 19, 2026Fracture
Component fractured.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332881 ↗InjuryAug 19, 2026Fracture
Component fractured.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332877 ↗InjuryJul 30, 2026Loss of Osseointegration
InjuryJul 30, 2026Loss of Osseointegration
InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754784 ↗InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754747 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479571 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479565 ↗InjuryJun 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25450660 ↗InjuryJun 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25450659 ↗InjuryMay 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25309822 ↗InjuryMay 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25309791 ↗InjuryMay 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25132975 ↗InjuryMay 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25132974 ↗InjuryMay 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074122 ↗InjuryMay 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074119 ↗InjuryApr 28, 2026Loss of Osseointegration
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.