NobelReplace® 36711 (UDI 07332747035667)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection RP 5.0x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace implant is placed in bone. Most of the 1,334 reports describe the implant losing or failing to bond with the bone, and some mention pain, infection or numbness. The reports include no deaths and 1,327 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
- 1,338
- Deaths reported
- 0
- Injuries reported
- 1,331
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,338 adverse event reports that list this exact device (DI 07332747035667), received between Jul 31, 2019 and Sep 30, 2026 — classified as 1,331 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (756 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 Osseointegration756
- Failure to Osseointegrate510
- Osseointegration Problem33
- Adverse Event Without Identified Device or Use Problem23
- Fracture9
- Insufficient Device Problem Information5
- Malposition of Device3
- Material Deformation2
Patient problems
- Failure of Implant1,198
- Pain276
- Unspecified Infection203
- No Clinical Signs, Symptoms or Conditions79
- Numbness16
- Abscess9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Inflammation8
Recent adverse event reports
The 25 most recent of 1,338 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953794 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953793 ↗InjuryAug 26, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463523 ↗InjuryAug 26, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463515 ↗InjuryAug 25, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441529 ↗InjuryAug 25, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441528 ↗InjuryAug 21, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382338 ↗InjuryAug 21, 2026Loss of Osseointegration
InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228602 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228597 ↗InjuryJul 31, 2026Loss of Osseointegration
InjuryJul 31, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030825 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030823 ↗InjuryJun 30, 2026Loss of Osseointegration
InjuryJun 30, 2026Loss of Osseointegration
InjuryJun 30, 2026Loss of Osseointegration
InjuryJun 30, 2026Loss of Osseointegration
InjuryJun 16, 2026Loss of Osseointegration
InjuryJun 16, 2026Loss of Osseointegration
InjuryJun 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25492919 ↗InjuryJun 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25492916 ↗InjuryJun 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25450574 ↗InjuryJun 9, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25450571 ↗InjuryJun 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25402167 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.