NobelReplace® 36701 (UDI 07332747035759)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection NP 3.5x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace implant is placed in bone. Most of the 1,335 reports describe the implant failing to bond with the bone or losing that bond, and some mention pain, infection or numbness. The reports include no deaths and 1,328 injuries. 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
- 1,339
- Deaths reported
- 0
- Injuries reported
- 1,332
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,339 adverse event reports that list this exact device (DI 07332747035759), received between Sep 10, 2019 and Sep 18, 2026 — classified as 1,332 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (708 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 Osseointegrate708
- Loss of Osseointegration555
- Osseointegration Problem33
- Fracture20
- Adverse Event Without Identified Device or Use Problem16
- Insufficient Device Problem Information2
- Migration2
- Premature Separation2
Patient problems
- Failure of Implant1,236
- Pain206
- Unspecified Infection118
- No Clinical Signs, Symptoms or Conditions73
- Numbness34
- Abscess6
- Inflammation5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
Recent adverse event reports
The 25 most recent of 1,339 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 50830391 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830390 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50701456 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50701454 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50267241 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50264918 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215486 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215484 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50214818 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50214817 ↗InjuryJul 31, 2026Failure to Osseointegrate
InjuryJul 31, 2026Failure to Osseointegrate
InjuryJul 29, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50076908 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030539 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030537 ↗InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
InjuryJun 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540484 ↗InjuryJun 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25539912 ↗InjuryMay 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25339867 ↗InjuryMay 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25339816 ↗InjuryMay 7, 2026Loss of Osseointegration
InjuryMay 7, 2026Loss of Osseointegration
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
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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.