Replace Select™ 37301 (UDI 07332747073485)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC NP 3.5x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant has 374 reports, with no deaths and 373 injuries. Most describe the implant failing to bond with the jawbone or losing that bond, while some mention fractures, unstable placement and infections. No recalls name this device. Recent reports fell from 16 to 2 compared with the period before.
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
- 374
- Deaths reported
- 0
- Injuries reported
- 373
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 374 adverse event reports that list this exact device (DI 07332747073485), received between Sep 11, 2019 and Dec 5, 2025 — classified as 373 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (163 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 Osseointegrate163
- Loss of Osseointegration159
- Fracture23
- Osseointegration Problem19
- Adverse Event Without Identified Device or Use Problem4
- Patient Device Interaction Problem4
- Naturally Worn2
Patient problems
- Failure of Implant358
- Pain46
- Unspecified Infection43
- No Clinical Signs, Symptoms or Conditions14
- Numbness4
- Abscess2
Recent adverse event reports
The 25 most recent of 374 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 5, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 15, 2025Osseointegration Problem; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23296286 ↗InjuryOct 15, 2025Osseointegration Problem; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23295450 ↗InjurySep 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23047236 ↗InjurySep 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23047235 ↗InjuryAug 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22722487 ↗InjuryAug 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22722457 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22444438 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22444413 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22444356 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22444351 ↗InjuryFeb 13, 2025Fracture; Fracture
InjuryFeb 13, 2025Fracture; Fracture
InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 19, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20719727 ↗InjuryNov 19, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20718690 ↗InjuryAug 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20079690 ↗InjuryAug 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20079539 ↗InjuryAug 22, 2024Fracture; Fracture
InjuryAug 22, 2024Fracture; Fracture
InjuryAug 22, 2024Fracture; Fracture
InjuryAug 22, 2024Fracture; Fracture
InjuryJun 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19523950 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.