NobelActive® 37808 (UDI 07332747088373)Recalls & reported problems
Nobel Biocare AB · NobelActive® WP 5.5x10mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelActive root-form implant is placed in bone. Most of the 1,358 reports describe the implant losing or failing to bond with the bone, and some mention pain, infection or numbness. The reports include no deaths and 1,352 injuries. 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
- 1,359
- Deaths reported
- 0
- Injuries reported
- 1,353
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,359 adverse event reports that list this exact device (DI 07332747088373), received between Sep 10, 2019 and Sep 8, 2026 — classified as 1,353 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (927 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 Osseointegration927
- Failure to Osseointegrate304
- Fracture42
- Osseointegration Problem39
- Adverse Event Without Identified Device or Use Problem21
- Insufficient Device Problem Information11
- Patient Device Interaction Problem6
- Malposition of Device4
Patient problems
- Failure of Implant1,192
- Pain264
- Unspecified Infection152
- No Clinical Signs, Symptoms or Conditions99
- Numbness23
- Inflammation12
- Insufficient Information10
- Abscess6
Recent adverse event reports
The 25 most recent of 1,359 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678627 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678624 ↗InjuryAug 26, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463431 ↗InjuryAug 26, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463430 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358051 ↗InjuryAug 7, 2026Loss of Osseointegration
InjuryAug 7, 2026Loss of Osseointegration
InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167673 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167669 ↗InjuryJul 31, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105923 ↗InjuryJul 31, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105920 ↗InjuryJul 16, 2026Loss of Osseointegration
InjuryJul 16, 2026Loss of Osseointegration
InjuryJul 8, 2026Loss of Osseointegration
InjuryJul 8, 2026Loss of Osseointegration
InjuryJul 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25708667 ↗InjuryJul 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25708641 ↗InjuryJun 23, 2026Loss of Osseointegration
InjuryJun 23, 2026Loss of Osseointegration
InjuryMay 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25266082 ↗InjuryMay 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25266080 ↗InjuryMay 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25249385 ↗InjuryMay 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25249372 ↗InjuryMay 12, 2026Loss of Osseointegration
InjuryMay 12, 2026Loss of Osseointegration
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page