NobelReplace® 37288 (UDI 07332747073614)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC NP 3.5x13mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace dental implant has 271 reports, with no deaths and 270 injuries. Most describe the implant failing to bond with the jawbone, or bonding and then loosening, and some describe pain or infection. Reports dropped sharply over the last 12 months, to 6 from 28 the year before. 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
- 271
- Deaths reported
- 0
- Injuries reported
- 270
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 271 adverse event reports that list this exact device (DI 07332747073614), received between Sep 11, 2019 and Jul 27, 2026 — classified as 270 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (147 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 Osseointegrate147
- Loss of Osseointegration103
- Osseointegration Problem10
- Fracture6
- Adverse Event Without Identified Device or Use Problem4
- Migration2
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant250
- Pain40
- Unspecified Infection26
- No Clinical Signs, Symptoms or Conditions15
- Numbness7
- Fistula2
Recent adverse event reports
The 25 most recent of 271 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryDec 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23844523 ↗InjuryDec 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23844489 ↗InjuryDec 2, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 2, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22695076 ↗InjuryAug 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22695065 ↗InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 9, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22463481 ↗InjuryJul 9, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22463476 ↗InjuryJul 8, 2025Migration; Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22452474 ↗InjuryJul 8, 2025Migration; Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22451338 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22449318 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22449316 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22449310 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22449308 ↗InjuryJun 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22351695 ↗InjuryJun 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22351685 ↗InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 31, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 31, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.