NobelReplace® 37284 (UDI 07332747073645)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC NP 3.5x8mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant is a post placed in the jawbone to support a replacement tooth. The 311 reports mostly describe the implant failing or losing its bond with the jawbone, with some reports of pain, infection and numbness. There are no deaths and 300 injuries reported, and no recalls name this device. Reports dropped from 18 in the year before to 3 in the latest year.
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
- 312
- Deaths reported
- 0
- Injuries reported
- 301
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 312 adverse event reports that list this exact device (DI 07332747073645), received between Sep 11, 2019 and Sep 25, 2026 — classified as 301 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (163 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 Osseointegrate163
- Loss of Osseointegration119
- Adverse Event Without Identified Device or Use Problem9
- Osseointegration Problem9
- Fracture6
- Premature Separation3
- Labelling, Instructions for Use or Training Problem2
- Difficult to Insert1
Patient problems
- Failure of Implant297
- Pain48
- Unspecified Infection21
- Numbness15
- No Clinical Signs, Symptoms or Conditions9
- Abscess2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Aspiration/Inhalation2
Recent adverse event reports
The 25 most recent of 312 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Failure to Osseointegrate
InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479246 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479241 ↗InjuryMar 20, 2026Loss of Osseointegration
InjuryAug 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22869291 ↗InjuryAug 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22867939 ↗InjuryJul 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 28, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22599861 ↗InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22598945 ↗InjuryJul 8, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22450315 ↗InjuryJul 8, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22450310 ↗InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22430366 ↗InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22430360 ↗MalfunctionMar 21, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
INCORRECT PART USED DUE TO INSUFFIC INFO.
Patient problems: Aspiration/Inhalation; Failure of Implant
MAUDE report 21670050 ↗InjuryMar 21, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
INCORRECT PART USED DUE TO INSUFFIC INFO.
Patient problems: Aspiration/Inhalation; Failure of Implant
MAUDE report 21670017 ↗InjuryDec 10, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20897396 ↗InjuryDec 10, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20897349 ↗InjuryDec 4, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 4, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 21, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 21, 2024Loss of Osseointegration; Loss of Osseointegration
InjurySep 11, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20194393 ↗InjurySep 11, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED, DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20194390 ↗InjurySep 11, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20194276 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.