NobelReplace® 32212Recalls & reported problems
Nobel Biocare AB · NobelReplace® Tapered Groovy NP 3.5x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant is placed into the jawbone. Its 2,040 adverse event reports, 2,034 of them injuries, mostly describe the implant losing its bond with the bone or failing to fuse with it, and some mention fractures, pain or infection. The reports include 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
- 2,042
- Deaths reported
- 0
- Injuries reported
- 2,036
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,042 adverse event reports that list this exact device (DI 07332747001808), received between Sep 11, 2019 and Sep 29, 2026 — classified as 2,036 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (1,393 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 Osseointegration1,393
- Failure to Osseointegrate507
- Osseointegration Problem61
- Fracture52
- Adverse Event Without Identified Device or Use Problem17
- Insufficient Device Problem Information6
- Material Deformation2
- Premature Separation2
Patient problems
- Failure of Implant1,678
- Pain304
- Unspecified Infection287
- No Clinical Signs, Symptoms or Conditions178
- Numbness44
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available38
- Abscess18
- Implant Pain12
Recent adverse event reports
The 25 most recent of 2,042 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50940294 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50940291 ↗InjuryAug 19, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50333242 ↗InjuryAug 19, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50333239 ↗InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263152 ↗InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263151 ↗InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 13, 2026Loss of Osseointegration
InjuryAug 13, 2026Loss of Osseointegration
InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228641 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228638 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228636 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228633 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228610 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228609 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228588 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228587 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166953 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50166951 ↗InjuryAug 3, 2026Loss of Osseointegration
InjuryAug 3, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030281 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030279 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50002341 ↗
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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.