NobelReplace® 36102Recalls & reported problems
Nobel Biocare AB · NobelReplace® Tapered Groovy WP 5.0x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace implant is placed into bone, and its 497 reports, including 496 injuries, mostly describe the implant losing its bond with the bone or never bonding at all. Reports also list infection, pain, and numbness. There are no deaths reported, and 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
- 499
- Deaths reported
- 0
- Injuries reported
- 498
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 499 adverse event reports that list this exact device (DI 07332747019278), received between Sep 11, 2019 and Sep 30, 2026 — classified as 498 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (336 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 Osseointegration336
- Failure to Osseointegrate150
- Fracture6
- Osseointegration Problem5
- Adverse Event Without Identified Device or Use Problem1
- Premature Separation1
Patient problems
- Failure of Implant401
- Unspecified Infection78
- Pain58
- No Clinical Signs, Symptoms or Conditions52
- Numbness14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Abscess6
- Implant Pain4
Recent adverse event reports
The 25 most recent of 499 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 50954485 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954478 ↗InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262933 ↗InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262929 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50215875 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50215872 ↗InjuryAug 8, 2026Loss of Osseointegration
Loss of osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187596 ↗InjuryAug 8, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187588 ↗InjuryJul 30, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50091652 ↗InjuryJul 30, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50091650 ↗InjuryJun 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25450289 ↗InjuryJun 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25450283 ↗InjuryJun 5, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25417754 ↗InjuryJun 5, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25416720 ↗InjuryMay 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 25266137 ↗InjuryMay 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 25266136 ↗InjuryMay 22, 2026Loss of Osseointegration
InjuryMay 22, 2026Loss of Osseointegration
InjuryMay 21, 2026Loss of Osseointegration
InjuryMay 21, 2026Loss of Osseointegration
InjuryMay 14, 2026Loss of Osseointegration
InjuryMay 14, 2026Loss of Osseointegration
InjuryApr 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25051824 ↗InjuryApr 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25051823 ↗InjuryApr 7, 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.