NobelActive® 37809 (UDI 07332747161151)Recalls & reported problems
Nobel Biocare AB · NobelActive® WP 5.5x11.5mm · Class 2 · Implant
Quick summary
This NobelActive implant from Nobel Biocare has 1,460 FDA adverse event reports, with 1,443 injuries, 17 malfunctions and no deaths. The reports mostly describe the bone not holding or bonding with the implant, sometimes after the implant felt unstable during placement, and some mention infections or pain. 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
- 1,478
- Deaths reported
- 0
- Injuries reported
- 1,461
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,478 adverse event reports that list this exact device (DI 07332747161151), received between Nov 3, 2021 and Sep 29, 2026 — classified as 1,461 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (884 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 Osseointegrate884
- Loss of Osseointegration327
- Osseointegration Problem129
- Patient Device Interaction Problem34
- Adverse Event Without Identified Device or Use Problem26
- Migration18
- Malposition of Device14
- Difficult to Insert10
Patient problems
- Failure of Implant1,034
- No Clinical Signs, Symptoms or Conditions339
- Unspecified Infection138
- Pain108
- Abscess21
- Numbness18
- Implant Pain14
- Inflammation12
Recent adverse event reports
The 25 most recent of 1,478 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940539 ↗InjurySep 29, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940538 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940362 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940359 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830754 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830753 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811792 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811791 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796138 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796127 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780444 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780442 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764609 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764607 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50749126 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50749125 ↗InjuryAug 27, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486884 ↗InjuryAug 27, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486882 ↗InjuryAug 26, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463673 ↗InjuryAug 26, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463669 ↗InjuryAug 26, 2026Loss of Osseointegration
InjuryAug 26, 2026Loss of Osseointegration
InjuryAug 25, 2026Loss of Osseointegration
InjuryAug 25, 2026Loss of Osseointegration
InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358174 ↗
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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.