NobelActive® 35219 (UDI 07332747017946)Recalls & reported problems
Nobel Biocare AB · NobelActive® Internal RP 4.3x18mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelActive implant is placed into bone. Most of the 307 reports describe the implant failing to bond with the surrounding bone, and some also mention fractures, pain, and infection. The reports include 306 injuries and no deaths, and no recalls name this device. Reports fell from 36 in the prior 12 months to 18 in the most recent 12 months.
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
- 311
- Deaths reported
- 0
- Injuries reported
- 310
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 311 adverse event reports that list this exact device (DI 07332747017946), received between Sep 11, 2019 and Sep 18, 2026 — classified as 310 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (162 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 Osseointegration162
- Failure to Osseointegrate96
- Fracture22
- Osseointegration Problem21
- Adverse Event Without Identified Device or Use Problem4
- Patient Device Interaction Problem3
- Insufficient Device Problem Information2
- Material Deformation1
Patient problems
- Failure of Implant264
- Pain74
- Unspecified Infection52
- No Clinical Signs, Symptoms or Conditions25
- Implant Pain6
- Numbness3
- Abscess2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 311 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 50830547 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830544 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830536 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830534 ↗InjuryAug 25, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440408 ↗InjuryAug 25, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440402 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25818874 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25818869 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601548 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601547 ↗InjuryMay 7, 2026Loss of Osseointegration
InjuryMay 7, 2026Loss of Osseointegration
InjuryApr 11, 2026Failure to Osseointegrate
InjuryApr 11, 2026Failure to Osseointegrate
InjuryApr 11, 2026Failure to Osseointegrate
InjuryApr 11, 2026Failure to Osseointegrate
InjuryApr 10, 2026Failure to Osseointegrate
InjuryApr 10, 2026Failure to Osseointegrate
InjuryMar 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24720985 ↗InjuryMar 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24720676 ↗InjuryJan 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24227028 ↗InjuryJan 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24227027 ↗InjuryOct 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 11, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23033338 ↗
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.