NobelActive® 35221 (UDI 07332747017939)Recalls & reported problems
Nobel Biocare AB · NobelActive® Internal NP 3.5x8.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelActive implant is a dental implant placed into the jawbone. Its 2,091 adverse event reports, 2,075 of them injuries, mostly describe the implant failing to fuse with the bone or losing its bond with it, and some mention pain, infection or numbness. 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
- 2,097
- Deaths reported
- 0
- Injuries reported
- 2,081
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,097 adverse event reports that list this exact device (DI 07332747017939), received between Sep 10, 2019 and Sep 18, 2026 — classified as 2,081 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,022 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
- Failure to Osseointegrate1,022
- Loss of Osseointegration898
- Osseointegration Problem60
- Adverse Event Without Identified Device or Use Problem55
- Fracture49
- Patient Device Interaction Problem6
- Malposition of Device4
- Insufficient Device Problem Information3
Patient problems
- Failure of Implant1,877
- Pain360
- Unspecified Infection194
- No Clinical Signs, Symptoms or Conditions164
- Numbness47
- Implant Pain12
- Abscess8
- Inflammation6
Recent adverse event reports
The 25 most recent of 2,097 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830708 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830707 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780720 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780716 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743813 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743811 ↗InjuryAug 19, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332633 ↗InjuryAug 19, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332630 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229047 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229044 ↗InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 4, 2026Loss of Osseointegration
InjuryAug 4, 2026Loss of Osseointegration
InjuryJul 29, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50076709 ↗InjuryJul 29, 2026Failure to Osseointegrate
Failure to osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50076088 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50013229 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50013226 ↗InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863147 ↗InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863108 ↗InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862985 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- 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.