NobelReplace® 36704 (UDI 07332747035728)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection RP 4.3x8mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace root-form implant has 1,241 adverse event reports, with no deaths and 1,237 injuries. Most reports describe the implant failing to bond with the surrounding bone. Patients also report pain, infection, or numbness. No recalls name this device. Reports in the last 12 months (75) are fewer than in the 12 months before (114).
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
- 1,243
- Deaths reported
- 0
- Injuries reported
- 1,239
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,243 adverse event reports that list this exact device (DI 07332747035728), received between Sep 11, 2019 and Sep 11, 2026 — classified as 1,239 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (689 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
- Loss of Osseointegration689
- Failure to Osseointegrate490
- Osseointegration Problem37
- Adverse Event Without Identified Device or Use Problem6
- Fracture5
- Material Deformation4
- Patient Device Interaction Problem4
- Insufficient Device Problem Information3
Patient problems
- Failure of Implant1,102
- Pain221
- Unspecified Infection144
- No Clinical Signs, Symptoms or Conditions88
- Numbness32
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- Inflammation6
- Abscess4
Recent adverse event reports
The 25 most recent of 1,243 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742998 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742997 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487130 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487129 ↗InjuryAug 13, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50243469 ↗InjuryAug 13, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50243467 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215657 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215649 ↗InjuryAug 5, 2026Loss of Osseointegration
InjuryAug 5, 2026Loss of Osseointegration
InjuryAug 3, 2026Loss of Osseointegration
InjuryAug 3, 2026Loss of Osseointegration
InjuryJul 30, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50093300 ↗InjuryJul 29, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50076891 ↗InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 16, 2026Loss of Osseointegration
InjuryJul 16, 2026Loss of Osseointegration
InjuryJul 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848609 ↗InjuryJul 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848580 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25819856 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25819847 ↗InjuryJun 27, 2026Loss of Osseointegration
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- 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.