NobelReplace® 37290 (UDI 07332747073591)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC RP 4.3x8mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelReplace dental implant is a post placed in the jawbone to hold a replacement tooth. Most of its 467 reports describe the implant failing to bond with the bone or losing that bond, with patients also mentioning pain, infection and numbness. The reports include 465 injuries, 2 malfunctions and no deaths. 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
- 467
- Deaths reported
- 0
- Injuries reported
- 465
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 467 adverse event reports that list this exact device (DI 07332747073591), received between Sep 11, 2019 and Sep 17, 2026 — classified as 465 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (225 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
- Failure to Osseointegrate225
- Loss of Osseointegration211
- Osseointegration Problem14
- Adverse Event Without Identified Device or Use Problem6
- Fracture6
- Patient Device Interaction Problem3
- Material Deformation1
- Migration1
Patient problems
- Failure of Implant415
- Pain65
- Unspecified Infection60
- No Clinical Signs, Symptoms or Conditions27
- Numbness10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Sinus Perforation3
- Implant Pain2
Recent adverse event reports
The 25 most recent of 467 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50811777 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50811775 ↗InjuryAug 18, 2026Failure to Osseointegrate
InjuryAug 18, 2026Failure to Osseointegrate
InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228369 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228368 ↗InjuryJul 16, 2026Loss of Osseointegration
InjuryJul 16, 2026Loss of Osseointegration
InjuryJun 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25613996 ↗InjuryJun 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25613983 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25600824 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25600823 ↗InjuryMay 31, 2026Loss of Osseointegration
InjuryMay 31, 2026Loss of Osseointegration
InjuryMay 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25130865 ↗InjuryMay 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25130719 ↗InjuryApr 24, 2026Loss of Osseointegration
InjuryApr 24, 2026Loss of Osseointegration
InjuryMar 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24576713 ↗InjuryMar 11, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24572358 ↗InjuryFeb 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24409689 ↗InjuryFeb 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24409686 ↗InjuryJan 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24217140 ↗InjuryJan 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24217135 ↗InjuryDec 5, 2025Loss of Osseointegration; Loss 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.
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