NobelActive® 37810 (UDI 07332747088359)Recalls & reported problems
Nobel Biocare AB · NobelActive® WP 5.5x13mm · Class 2 · Implant
All models of NobelActive (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelActive is a dental implant placed into the jawbone. Many of its 299 reports describe the implant losing bone integration or failing to bond with bone, and some mention pain or infection. The reports mention no deaths and 297 injuries. Reports fell from 36 in the 12 months before to 16 in the latest 12 months. 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
- 301
- Deaths reported
- 0
- Injuries reported
- 299
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 301 adverse event reports that list this exact device (DI 07332747088359), received between Sep 11, 2019 and Sep 16, 2026 — classified as 299 injuries, 2 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration162
- Failure to Osseointegrate106
- Fracture12
- Osseointegration Problem12
- Adverse Event Without Identified Device or Use Problem10
Patient problems
- Failure of Implant261
- Pain71
- Unspecified Infection47
- No Clinical Signs, Symptoms or Conditions28
- Fistula4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Inflammation2
- Numbness1
Recent adverse event reports
The 25 most recent of 301 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796133 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796130 ↗InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754136 ↗InjuryJul 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754119 ↗InjuryApr 29, 2026Loss of Osseointegration
InjuryApr 29, 2026Loss of Osseointegration
InjuryApr 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25029490 ↗InjuryApr 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25023138 ↗InjuryApr 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24786247 ↗InjuryApr 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24786242 ↗InjuryMar 7, 2026Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24541538 ↗InjuryMar 7, 2026Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24540238 ↗InjuryFeb 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24410041 ↗InjuryFeb 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24410038 ↗InjuryFeb 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24253884 ↗InjuryFeb 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24253880 ↗InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23560994 ↗InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23560986 ↗InjuryOct 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22763936 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22763935 ↗InjuryAug 8, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22761667 ↗InjuryAug 8, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22761666 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22757697 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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