NobelParallel™ Conical Connection TiUltra™ 300316Recalls & reported problems
Nobel Biocare AB · NobelParallel™ Conical Connection TiUltra™ WP 5.5x7mm · Class 2 · Implant
All models of NobelParallel Conical Connection TiUltra (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelParallel implant is placed into bone, and its 496 reports, including 485 injuries, mostly describe the implant not bonding with the bone or losing its hold. Reports also list infection, pain, and inflammation. There are no deaths reported, and no recalls name this device. Reports fell to 76 in the past year from 106 in the year 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
- 504
- Deaths reported
- 0
- Injuries reported
- 493
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 504 adverse event reports that list this exact device (DI 07332747128093), received between Nov 8, 2021 and Sep 30, 2026 — classified as 493 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (311 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate311
- Loss of Osseointegration121
- Osseointegration Problem26
- Premature Separation16
- Adverse Event Without Identified Device or Use Problem12
- Patient Device Interaction Problem8
- Activation, Positioning or Separation Problem4
- Device Markings/Labelling Problem4
Patient problems
- Failure of Implant330
- No Clinical Signs, Symptoms or Conditions123
- Unspecified Infection27
- Pain24
- Inflammation12
- Abscess10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Implant Pain6
Recent adverse event reports
The 25 most recent of 504 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953711 ↗InjurySep 30, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953710 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50940630 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50940619 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 50780677 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 50780670 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700821 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700820 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50485599 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50485598 ↗InjuryAug 25, 2026Failure to Osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50441556 ↗InjuryAug 25, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50441555 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50358673 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50358672 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228380 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228379 ↗InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183792 ↗InjuryAug 7, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183790 ↗InjuryAug 4, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50135558 ↗InjuryAug 4, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50135555 ↗InjuryAug 4, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50135305 ↗InjuryAug 4, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50135302 ↗InjuryJul 31, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107013 ↗InjuryJul 31, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107009 ↗InjuryJul 3, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25708761 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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