NobelActive® 37811 (UDI 07332747088342)Recalls & reported problems
Nobel Biocare AB · NobelActive® WP 5.5x15mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelActive dental implant is a root-form implant placed in the jawbone. Its 101 FDA reports include 99 injuries and no deaths, and mostly say the implant lost or failed to bond with the jawbone, with some describing infection and pain. Reports fell to 4 in the last 12 months from 14 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
- 99
- Deaths reported
- 0
- Injuries reported
- 97
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 07332747088342), received between Sep 12, 2019 and Dec 9, 2025 — classified as 97 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (43 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 Osseointegration43
- Failure to Osseointegrate42
- Adverse Event Without Identified Device or Use Problem6
- Osseointegration Problem4
- Fracture2
- Migration2
Patient problems
- Failure of Implant87
- Unspecified Infection16
- Pain10
- No Clinical Signs, Symptoms or Conditions8
- Foreign Body In Patient2
- Implant Pain2
- Numbness2
- Sinus Perforation2
Recent adverse event reports
The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.
InjuryDec 9, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23762807 ↗InjuryDec 9, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23762806 ↗InjurySep 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22973369 ↗InjurySep 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22972960 ↗InjuryAug 13, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 13, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22760707 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22760706 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22454388 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22454383 ↗InjuryFeb 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 13, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 12, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryOct 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20574333 ↗InjuryOct 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20573964 ↗InjuryOct 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20573777 ↗InjuryOct 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20573532 ↗InjuryJul 15, 2024Migration; Migration
IMPLANT FAILED DUE TO PART MIGRATES.
Patient problems: Foreign Body In Patient
MAUDE report 19744566 ↗InjuryJul 15, 2024Migration; Migration
IMPLANT FAILED DUE TO PART MIGRATES.
Patient problems: Foreign Body In Patient
MAUDE report 19744505 ↗InjuryMay 27, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 19401892 ↗InjuryMay 27, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 19401891 ↗InjuryJan 9, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18478939 ↗
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- 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 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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