NobelReplace® 37287 (UDI 07332747073621)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC NP 3.5x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace conical implant is set into the jawbone to support a replacement tooth. The 309 reports mostly describe the implant failing to bond with the bone, with some reports of pain and infection. There are no deaths and 306 injuries reported, and no recalls name this device. Reports dropped from 20 in the year before to 4 in the latest year.
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
- 311
- Deaths reported
- 0
- Injuries reported
- 308
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 311 adverse event reports that list this exact device (DI 07332747073621), received between Sep 11, 2019 and Sep 29, 2026 — classified as 308 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (178 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 Osseointegrate178
- Loss of Osseointegration104
- Fracture13
- Adverse Event Without Identified Device or Use Problem6
- Osseointegration Problem6
- Defective Device1
- Device Damaged by Another Device1
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant290
- Pain55
- Unspecified Infection25
- Numbness10
- No Clinical Signs, Symptoms or Conditions7
- Abscess4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Implant Pain2
Recent adverse event reports
The 25 most recent of 311 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Loss of Osseointegration
Patient problems: Implant Pain
MAUDE report 50940293 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: Implant Pain
MAUDE report 50940290 ↗InjuryMay 6, 2026Loss of Osseointegration
InjuryMay 6, 2026Loss of Osseointegration
InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23470680 ↗InjuryNov 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23470672 ↗InjuryOct 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22869297 ↗InjuryAug 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22867338 ↗InjuryAug 8, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22761032 ↗InjuryAug 8, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22761031 ↗InjuryJul 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22681770 ↗InjuryJul 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22681766 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 26, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 21, 2025Fracture; Fracture
InjuryMar 21, 2025Fracture; Fracture
InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 6, 2024Loss of Osseointegration; Loss of Osseointegration
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.