NobelReplace® 37290 (UDI 07332747160703)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC RP 4.3x8mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant is placed in the jawbone. The reports mostly describe implants that failed to bond with the bone, with some also mentioning infection, pain or numbness. FDA records list 5,609 reports, no deaths, 5,581 injuries and 28 malfunctions. No recalls name this device. Reports fell from 1,941 in the prior 12 months to 1,306 in the latest 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
- 5,696
- Deaths reported
- 0
- Injuries reported
- 5,668
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5,696 adverse event reports that list this exact device (DI 07332747160703), received between Oct 29, 2021 and Sep 29, 2026 — classified as 5,668 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4,604 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 Osseointegrate4,604
- Loss of Osseointegration808
- Osseointegration Problem160
- Adverse Event Without Identified Device or Use Problem44
- Patient Device Interaction Problem29
- Fracture13
- Migration11
- Premature Separation7
Patient problems
- Failure of Implant3,255
- No Clinical Signs, Symptoms or Conditions1,781
- Unspecified Infection684
- Pain384
- Numbness135
- Inflammation95
- Implant Pain74
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available70
Recent adverse event reports
The 25 most recent of 5,696 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940195 ↗InjurySep 29, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940187 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940016 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940014 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939293 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939290 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924890 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924889 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924698 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924695 ↗InjurySep 20, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834871 ↗InjurySep 20, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834857 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50833260 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50833259 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833012 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833010 ↗InjurySep 18, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830311 ↗InjurySep 18, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830308 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830176 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830173 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830035 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830034 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829974 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829968 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811245 ↗
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.