NobelReplace® 36710 (UDI 07332747035674)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection RP 5.0x8mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelReplace dental implant is placed in the jawbone. Its 819 reports include 808 injuries and no deaths. Most describe the implant losing its bond with the bone or never bonding, and some describe pain and infection. 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
- 821
- Deaths reported
- 0
- Injuries reported
- 810
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 821 adverse event reports that list this exact device (DI 07332747035674), received between Sep 11, 2019 and Sep 28, 2026 — classified as 810 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (439 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 Osseointegration439
- Failure to Osseointegrate322
- Osseointegration Problem32
- Adverse Event Without Identified Device or Use Problem18
- Insufficient Device Problem Information4
- Fracture3
- Malposition of Device3
- Material Deformation3
Patient problems
- Failure of Implant729
- Pain134
- Unspecified Infection106
- No Clinical Signs, Symptoms or Conditions56
- Numbness27
- Abscess7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Inflammation6
Recent adverse event reports
The 25 most recent of 821 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924539 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924538 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830752 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830750 ↗InjuryAug 18, 2026Loss of Osseointegration
InjuryAug 18, 2026Loss of Osseointegration
InjuryAug 18, 2026Loss of Osseointegration
InjuryAug 18, 2026Loss of Osseointegration
InjuryAug 11, 2026Loss of Osseointegration
InjuryAug 11, 2026Loss of Osseointegration
InjuryJul 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50062191 ↗InjuryJul 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50062190 ↗InjuryJul 2, 2026Failure to Osseointegrate
InjuryJul 2, 2026Failure to Osseointegrate
InjuryJun 5, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25416924 ↗InjuryJun 5, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25416830 ↗InjuryMay 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25224427 ↗InjuryMay 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25224423 ↗InjuryMay 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25165883 ↗InjuryMay 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25165881 ↗InjuryApr 29, 2026Loss of Osseointegration
InjuryApr 29, 2026Loss of Osseointegration
InjuryApr 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24992997 ↗InjuryApr 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24992992 ↗InjuryApr 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24837301 ↗
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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