NobelReplace® 36101Recalls & reported problems
Nobel Biocare AB · NobelReplace® Tapered Groovy RP 4.3x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant is placed in the jawbone. Most of its 1,157 reports describe implants that lose or fail to fuse with the bone, and some mention infection, pain and numbness. The reports include 1,155 injuries and 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
- 1,159
- Deaths reported
- 0
- Injuries reported
- 1,157
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,159 adverse event reports that list this exact device (DI 07332747019261), received between Sep 11, 2019 and Sep 30, 2026 — classified as 1,157 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (734 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 Osseointegration734
- Failure to Osseointegrate384
- Fracture15
- Osseointegration Problem12
- Adverse Event Without Identified Device or Use Problem10
- Mechanical Problem2
- Migration1
- Separation Failure1
Patient problems
- Failure of Implant946
- Unspecified Infection186
- Pain168
- No Clinical Signs, Symptoms or Conditions84
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available34
- Numbness25
- Abscess17
- Implant Pain4
Recent adverse event reports
The 25 most recent of 1,159 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954487 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954484 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939432 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939431 ↗InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50183728 ↗InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50183724 ↗InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25832321 ↗InjuryJul 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25832218 ↗InjuryJun 30, 2026Loss of Osseointegration
InjuryJun 30, 2026Loss of Osseointegration
InjuryJun 17, 2026Loss of Osseointegration
InjuryJun 17, 2026Loss of Osseointegration
InjuryJun 10, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464668 ↗InjuryJun 10, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464667 ↗InjuryJun 3, 2026Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25384593 ↗InjuryJun 3, 2026Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25384590 ↗InjuryMay 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25130716 ↗
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- 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.