NobelReplace® 37292 (UDI 07332747073577)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC RP 4.3x11.5mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelReplace implant is a root-form implant that is anchored in bone. Its 417 reports mostly describe the implant failing to bond with the bone, and some describe fractures. The reports include no deaths and 413 injuries. 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
- 417
- Deaths reported
- 0
- Injuries reported
- 413
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 417 adverse event reports that list this exact device (DI 07332747073577), received between Sep 11, 2019 and Jul 13, 2026 — classified as 413 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (205 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
- Failure to Osseointegrate205
- Loss of Osseointegration170
- Osseointegration Problem22
- Fracture12
- Adverse Event Without Identified Device or Use Problem6
- Premature Separation1
- Separation Failure1
Patient problems
- Failure of Implant389
- Pain73
- Unspecified Infection43
- Numbness20
- No Clinical Signs, Symptoms or Conditions13
- Inflammation4
- Implant Pain2
- Abscess1
Recent adverse event reports
The 25 most recent of 417 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2026Loss of Osseointegration
InjuryJul 13, 2026Loss of Osseointegration
InjuryJul 13, 2026Loss of Osseointegration
InjuryJul 13, 2026Loss of Osseointegration
InjuryJun 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25567382 ↗InjuryJan 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24138815 ↗InjuryJan 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24138812 ↗InjuryJan 7, 2026Loss of Osseointegration
InjuryJan 7, 2026Loss of Osseointegration
InjuryDec 5, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23734199 ↗InjuryDec 5, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23734198 ↗InjuryDec 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 8, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22763930 ↗InjuryAug 8, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22763926 ↗InjuryAug 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22759719 ↗InjuryAug 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22759717 ↗InjuryJul 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22630570 ↗InjuryJul 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22623500 ↗InjuryJul 9, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22464146 ↗InjuryJul 9, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22464111 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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