NobelReplace® 36708 (UDI 07332747035698)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection RP 4.3x13mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace implant is a screw-shaped device placed into bone. The 1,023 reports mostly describe the implant failing to bond with the bone or losing that bond, sometimes with pain or infection. There are 1,014 injury reports, 9 malfunction reports and no deaths. 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
- 1,027
- Deaths reported
- 0
- Injuries reported
- 1,018
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,027 adverse event reports that list this exact device (DI 07332747035698), received between Sep 11, 2019 and Sep 14, 2026 — classified as 1,018 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (509 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 Osseointegration509
- Failure to Osseointegrate453
- Osseointegration Problem20
- Adverse Event Without Identified Device or Use Problem18
- Fracture15
- Insufficient Device Problem Information7
- Migration4
- Device Damaged by Another Device1
Patient problems
- Failure of Implant937
- Pain158
- Unspecified Infection82
- No Clinical Signs, Symptoms or Conditions71
- Numbness24
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Abscess3
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 1,027 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748553 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748552 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50701471 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50701467 ↗InjuryAug 8, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187902 ↗InjuryAug 8, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187900 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167358 ↗InjuryAug 6, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167357 ↗InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25804974 ↗InjuryJul 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25804973 ↗InjuryJul 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711976 ↗InjuryJul 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711965 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479379 ↗InjuryJun 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479375 ↗InjuryJun 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25402142 ↗InjuryJun 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25402136 ↗InjuryApr 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25023378 ↗InjuryApr 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25022982 ↗InjuryApr 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24973541 ↗InjuryApr 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24973312 ↗InjuryApr 17, 2026Fracture
InjuryApr 17, 2026Fracture
InjuryApr 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24837047 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.