NobelReplace® 32161Recalls & reported problems
Nobel Biocare AB · NOBELREPLACE Straight Groovy NP 3.5x11.5 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This NobelReplace Straight Groovy dental implant, a screw-shaped root-form implant used to replace a missing tooth, appears in 68 adverse event reports with68 injuries and no deaths. Most reports describe the implant not fusing properly with the surrounding bone, so it fails and has to be removed, along with reports of the implant component fracturing and patients reporting pain, infection, abscess and swelling. There are no recalls naming this device, and reports have fallen from 16 in the prior 12 months to 6 in the last 12 months.
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
- 68
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 07332747019018), received between Nov 7, 2021 and May 22, 2026 — classified as 68 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (52 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 Osseointegration52
- Failure to Osseointegrate8
- Fracture8
Patient problems
- Failure of Implant52
- Pain16
- Unspecified Infection14
- Abscess4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Inflammation2
- No Clinical Signs, Symptoms or Conditions2
- Numbness2
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25262482 ↗InjuryMay 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25262441 ↗InjuryApr 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25036545 ↗InjuryApr 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25036535 ↗InjuryJan 22, 2026Loss of Osseointegration
InjuryJan 22, 2026Loss of Osseointegration
InjuryJul 15, 2025Fracture; Fracture
InjuryJul 15, 2025Fracture; Fracture
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 26, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 26, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21670339 ↗InjuryMar 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21670303 ↗InjuryJan 27, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 27, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 21, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20014566 ↗InjuryAug 20, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20002172 ↗InjuryApr 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19168273 ↗
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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