NobelReplace® 37285 (UDI 07332747073638)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC NP 3.5x10mm · Class 2 · Implant
All models of NobelReplace (120)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelReplace dental implant has 517 adverse event reports, with no deaths and 514 injuries. Most reports describe the implant losing its bond with bone or failing to fuse with it, and some mention pain, infection and numbness. 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
- 517
- Deaths reported
- 0
- Injuries reported
- 514
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 517 adverse event reports that list this exact device (DI 07332747073638), received between Sep 11, 2019 and Apr 17, 2026 — classified as 514 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (276 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate276
- Loss of Osseointegration194
- Osseointegration Problem31
- Fracture11
- Adverse Event Without Identified Device or Use Problem1
- Mechanical Problem1
- Migration1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant478
- Pain91
- Unspecified Infection45
- No Clinical Signs, Symptoms or Conditions17
- Numbness14
- Implant Pain4
- Inflammation4
- Abscess3
Recent adverse event reports
The 25 most recent of 517 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917692 ↗InjuryApr 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24917687 ↗InjuryMar 3, 2026Loss of Osseointegration
InjuryMar 3, 2026Loss of Osseointegration
InjuryFeb 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24447698 ↗InjuryFeb 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24447695 ↗InjuryFeb 21, 2026Failure to Osseointegrate
InjuryFeb 21, 2026Failure to Osseointegrate
InjuryFeb 19, 2026Failure to Osseointegrate
InjuryFeb 19, 2026Failure to Osseointegrate
InjuryFeb 3, 2026Fracture
InjuryFeb 3, 2026Fracture
InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833580 ↗InjuryDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23833518 ↗InjuryDec 5, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 5, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23677190 ↗InjuryNov 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23677189 ↗InjuryOct 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 23432449 ↗InjuryOct 30, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 23432446 ↗InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 25, 2025Fracture; Fracture
COMPONENT FRACTURED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22619350 ↗
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- 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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