NobelActive® 37807 (UDI 07332747088380)Recalls & reported problems
Nobel Biocare AB · NobelActive® WP 5.5x8.5mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelActive bone implant has 762 reports, with no deaths and 762 injuries. Most reports describe the implant losing its bond with the bone, and some mention fractures. Reports fell to 46 in the past 12 months from 106 in the 12 months before. 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
- 770
- Deaths reported
- 0
- Injuries reported
- 770
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 770 adverse event reports that list this exact device (DI 07332747088380), received between Sep 10, 2019 and Sep 18, 2026 — classified as 770 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (488 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 Osseointegration488
- Failure to Osseointegrate221
- Osseointegration Problem38
- Fracture10
- Insufficient Device Problem Information6
- Adverse Event Without Identified Device or Use Problem5
- Mechanical Problem2
Patient problems
- Failure of Implant658
- Pain158
- Unspecified Infection97
- No Clinical Signs, Symptoms or Conditions62
- Numbness18
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Insufficient Information6
- Abscess4
Recent adverse event reports
The 25 most recent of 770 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 50830611 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830609 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796151 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796149 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50723912 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50723911 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486744 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486739 ↗InjuryAug 21, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382122 ↗InjuryAug 19, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333008 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50267050 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50264917 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 50167874 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 50167872 ↗InjuryAug 4, 2026Loss of Osseointegration
InjuryAug 4, 2026Loss of Osseointegration
InjuryJul 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25806351 ↗InjuryJul 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25806349 ↗InjuryJun 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540574 ↗InjuryJun 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540421 ↗InjuryJun 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25450861 ↗InjuryJun 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25450838 ↗InjuryMay 5, 2026Loss of Osseointegration
InjuryMay 5, 2026Loss of Osseointegration
InjuryApr 23, 2026Loss of Osseointegration
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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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