NobelReplace® 36713 (UDI 07332747035643)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection RP 5.0x13mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace implant is a root-form implant that is anchored in bone. Its 418 reports mostly describe the implant failing to bond with the bone. Reports fell in the most recent 12 months, with 32 compared with 81 in the 12 months before. The reports include no deaths and 413 injuries, 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
- 423
- Deaths reported
- 0
- Injuries reported
- 418
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 423 adverse event reports that list this exact device (DI 07332747035643), received between Sep 11, 2019 and Sep 18, 2026 — classified as 418 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (218 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 Osseointegration218
- Failure to Osseointegrate176
- Osseointegration Problem12
- Adverse Event Without Identified Device or Use Problem10
- Patient Device Interaction Problem5
- Fracture2
Patient problems
- Failure of Implant350
- Pain65
- No Clinical Signs, Symptoms or Conditions56
- Unspecified Infection54
- Abscess8
- Numbness5
- Implant Pain2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 423 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830073 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830070 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811850 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811849 ↗InjuryAug 26, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463600 ↗InjuryAug 26, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463593 ↗InjuryAug 19, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333042 ↗InjuryJul 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50062939 ↗InjuryJul 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50062937 ↗InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862836 ↗InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862835 ↗InjuryJun 21, 2026Loss of Osseointegration
InjuryJun 21, 2026Loss of Osseointegration
InjuryJun 5, 2026Loss of Osseointegration
InjuryJun 5, 2026Loss of Osseointegration
InjuryMar 14, 2026Loss of Osseointegration
InjuryMar 14, 2026Loss of Osseointegration
InjuryMar 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24587212 ↗InjuryMar 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24587207 ↗InjuryMar 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24585150 ↗InjuryMar 12, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24585114 ↗InjuryFeb 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24396629 ↗InjuryFeb 19, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24396593 ↗InjuryFeb 18, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24382126 ↗InjuryFeb 18, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24382112 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.