NobelReplace® 37294 (UDI 07332747160741)Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection PMC RP 4.3x16mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelReplace implant is a device placed into bone. The 235 reports mostly describe the implant failing to fuse with the bone, and some describe it losing its hold later. The reports include 231 injuries and no deaths, and reports fell to 38 in the last 12 months from 66 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
- 237
- Deaths reported
- 0
- Injuries reported
- 233
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 07332747160741), received between Oct 29, 2021 and Sep 17, 2026 — classified as 233 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (183 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 Osseointegrate183
- Loss of Osseointegration31
- Osseointegration Problem15
- Adverse Event Without Identified Device or Use Problem2
- Migration2
- Device Markings/Labelling Problem1
- Fracture1
- Malposition of Device1
Patient problems
- Failure of Implant152
- No Clinical Signs, Symptoms or Conditions71
- Unspecified Infection19
- Pain16
- Implant Pain2
- Inflammation2
- Numbness1
Recent adverse event reports
The 25 most recent of 237 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811627 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811623 ↗InjuryJul 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862600 ↗InjuryJul 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25862598 ↗InjuryJul 17, 2026Failure to Osseointegrate
InjuryJul 17, 2026Failure to Osseointegrate
InjuryJul 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25698580 ↗InjuryJul 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25698574 ↗InjuryMay 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25249603 ↗InjuryMay 21, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25249602 ↗InjuryMay 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117586 ↗InjuryMay 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117575 ↗InjuryMay 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117523 ↗InjuryMay 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117522 ↗InjuryApr 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783846 ↗InjuryApr 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24783153 ↗InjuryMar 13, 2026Failure to Osseointegrate
InjuryMar 13, 2026Failure to Osseointegrate
InjuryMar 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24501638 ↗InjuryMar 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24501633 ↗InjuryJan 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228120 ↗InjuryJan 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228116 ↗InjuryJan 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228106 ↗InjuryJan 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228101 ↗InjuryJan 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228099 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.