NobelActive® 36769 (UDI 07332747037739)Recalls & reported problems

Nobel Biocare AB · NobelActive® 3.0 3.0x10mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This Nobel Biocare NobelActive dental implant is placed in the jaw. Its 702 reports, with 690 injuries and no deaths, mostly describe the implant failing to fuse with the jawbone or losing that bond, with some mentioning pain, infection and numbness. No recalls name this device, and reports in the last 12 months number 26, down from 68 in the year before.

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: 704
Deaths reported: 0
Injuries reported: 692
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 704 adverse event reports that list this exact device (DI 07332747037739), received between Sep 10, 2019 and Sep 18, 2026 — classified as 692 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (433 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Osseointegrate433
Loss of Osseointegration196
Adverse Event Without Identified Device or Use Problem25
Osseointegration Problem24
Fracture13
Insufficient Device Problem Information5
Device Damaged by Another Device2
Difficult to Remove2

Patient problems

Failure of Implant636
Pain107
No Clinical Signs, Symptoms or Conditions52
Unspecified Infection50
Numbness28
Insufficient Information4
Fistula3
Abscess2

Recent adverse event reports

The 25 most recent of 704 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 50830796 ↗
InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830792 ↗
InjuryJul 5, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25712962 ↗
InjuryJul 5, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25712958 ↗
InjuryMay 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25324875 ↗
InjuryMay 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25324870 ↗
InjuryApr 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917725 ↗
InjuryApr 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917724 ↗
InjuryApr 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 24771484 ↗
InjuryApr 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 24771483 ↗
InjuryMar 18, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24635266 ↗
InjuryMar 18, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24632761 ↗
InjuryFeb 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24396412 ↗
InjuryFeb 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24396404 ↗
InjuryJan 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24061994 ↗
InjuryJan 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24061992 ↗
InjuryDec 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23845564 ↗
InjuryDec 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23845442 ↗
InjuryDec 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 23722039 ↗
InjuryDec 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 23722023 ↗
InjuryNov 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23662437 ↗
InjuryNov 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23662417 ↗
InjuryNov 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23662411 ↗
InjuryNov 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23662405 ↗
InjuryNov 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23503249 ↗

Device details

UDI-DI	`07332747037739`
Brand	NobelActive®
Model	36769
Company	Nobel Biocare AB
Product code	DZE · IMPLANT, ENDOSSEOUS, ROOT-FORM
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Oct 12, 2023

Device type (GMDN): Screw endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
43,616 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
40,404 reports
Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
27,400 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
25,621 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
25,298 reports
Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
23,448 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
22,320 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
22,267 reports

All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

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.

How reports and recalls are matched · Editorial policy · Report an error on this page