NobelActive® 37806 (UDI 07332747161120)Recalls & reported problems
Nobel Biocare AB · NobelActive® WP 5.5x7mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelActive implant is a screw-shaped device placed into bone. The 1,020 reports mostly describe the implant failing to bond with the bone, sometimes with pain or infection. There are 1,007 injury reports, 13 malfunction reports and no deaths. Reports fell from 220 in the prior 12 months to 140 in the last 12. 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
- 1,024
- Deaths reported
- 0
- Injuries reported
- 1,011
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,024 adverse event reports that list this exact device (DI 07332747161120), received between Nov 1, 2021 and Sep 18, 2026 — classified as 1,011 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (584 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 Osseointegrate584
- Loss of Osseointegration298
- Osseointegration Problem72
- Adverse Event Without Identified Device or Use Problem20
- Patient Device Interaction Problem14
- Migration10
- Difficult to Insert8
- Device Markings/Labelling Problem4
Patient problems
- Failure of Implant750
- No Clinical Signs, Symptoms or Conditions190
- Pain94
- Unspecified Infection86
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available14
- Inflammation12
- Abscess10
- Numbness8
Recent adverse event reports
The 25 most recent of 1,024 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50830207 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50830203 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741996 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741992 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486515 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486509 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486439 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486438 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486421 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486420 ↗InjuryAug 25, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440363 ↗InjuryAug 25, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440362 ↗InjuryAug 13, 2026Osseointegration Problem
Primary stability couldn¿t be achieve.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243491 ↗InjuryAug 13, 2026Osseointegration Problem
Primary stability couldn¿t be achieve.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243483 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215439 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215435 ↗InjuryAug 6, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167443 ↗InjuryAug 6, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167440 ↗InjuryAug 3, 2026Failure to Osseointegrate
InjuryAug 3, 2026Failure to Osseointegrate
InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50027225 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026892 ↗InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848735 ↗
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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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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