NobelReplace® 32183Recalls & reported problems
Nobel Biocare AB · NOBELREPLACE® Straight Groovy RP 4x13mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelReplace dental implant is a root-form implant placed in bone. Its 220 reports, all of which are injuries, mostly describe the implant losing its bond with bone, with some mentioning infection, pain and numbness. There were 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
- 236
- Deaths reported
- 0
- Injuries reported
- 236
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 236 adverse event reports that list this exact device (DI 07332747019100), received between Sep 13, 2019 and Sep 19, 2026 — classified as 236 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (188 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 Osseointegration188
- Fracture16
- Osseointegration Problem12
- Adverse Event Without Identified Device or Use Problem10
- Failure to Osseointegrate10
Patient problems
- Failure of Implant162
- Unspecified Infection66
- Pain38
- No Clinical Signs, Symptoms or Conditions30
- Fistula8
- Numbness8
- Abscess4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 25 most recent of 236 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50833633 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50833630 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830859 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830849 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830846 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830844 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830834 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830829 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487056 ↗InjuryAug 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487045 ↗InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 3, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110777 ↗InjuryAug 3, 2026Loss of Osseointegration
Loss of osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110775 ↗InjuryJul 9, 2026Loss of Osseointegration
InjuryJul 9, 2026Loss of Osseointegration
InjuryJul 9, 2026Loss of Osseointegration
InjuryJul 9, 2026Loss of Osseointegration
InjuryJun 25, 2026Loss of Osseointegration
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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