NobelReplace® 37298 (UDI 07332747073515)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC RP 5.0x13mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace implant is a device placed into bone. The 235 reports mostly describe the implant losing its hold in the bone or failing to fuse with it. The reports include 235 injuries and no deaths, and reports fell to 2 in the last 12 months from 44 in the 12 months 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
- 235
- Deaths reported
- 0
- Injuries reported
- 235
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 235 adverse event reports that list this exact device (DI 07332747073515), received between Sep 11, 2019 and Feb 21, 2026 — classified as 235 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (119 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 Osseointegration119
- Failure to Osseointegrate97
- Osseointegration Problem9
- Patient Device Interaction Problem5
- Adverse Event Without Identified Device or Use Problem4
- Premature Separation1
Patient problems
- Failure of Implant217
- Pain18
- Unspecified Infection10
- No Clinical Signs, Symptoms or Conditions9
- Implant Pain4
- Numbness3
- Abscess2
- Inflammation2
Recent adverse event reports
The 25 most recent of 235 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2026Loss of Osseointegration
InjuryFeb 21, 2026Loss of Osseointegration
InjurySep 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22985119 ↗InjurySep 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22985113 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22651655 ↗InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22651647 ↗InjuryJul 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 7, 2025Osseointegration Problem; Osseointegration Problem
InjuryJul 7, 2025Osseointegration Problem; Osseointegration Problem
InjuryApr 22, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
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.