NobelReplace® 36705 (UDI 07332747035711)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection RP 4.3x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant is placed in the jawbone. Its 2,357 reports include 2,349 injury reports, and most describe the implant not bonding with the bone or losing that bond. They also mention pain, infection and numbness. There are no deaths, 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
- 2,363
- Deaths reported
- 0
- Injuries reported
- 2,355
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,363 adverse event reports that list this exact device (DI 07332747035711), received between Jan 31, 2019 and Sep 29, 2026 — classified as 2,355 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (1,254 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 Osseointegration1,254
- Failure to Osseointegrate957
- Osseointegration Problem61
- Fracture46
- Adverse Event Without Identified Device or Use Problem24
- Insufficient Device Problem Information6
- Premature Separation6
- Mechanical Problem5
Patient problems
- Failure of Implant2,218
- Pain469
- Unspecified Infection285
- No Clinical Signs, Symptoms or Conditions91
- Numbness61
- Abscess13
- Inflammation9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
Recent adverse event reports
The 25 most recent of 2,363 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50940552 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50940550 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699814 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699809 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215449 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215446 ↗InjuryJul 31, 2026Failure to Osseointegrate
InjuryJul 31, 2026Failure to Osseointegrate
InjuryJul 31, 2026Failure to Osseointegrate
InjuryJul 31, 2026Failure to Osseointegrate
InjuryJul 30, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50092849 ↗InjuryJul 30, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50092848 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50014936 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50014933 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25819841 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25819826 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25819542 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25819525 ↗InjuryJul 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25697845 ↗InjuryJul 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25697838 ↗InjuryJun 30, 2026Loss of Osseointegration
InjuryJun 30, 2026Loss of Osseointegration
InjuryJun 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25554643 ↗InjuryJun 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25554617 ↗InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25384292 ↗
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.