NobelParallel™ Conical Connection TiUltra™ 300308Recalls & reported problems
Nobel Biocare AB · NobelParallel™ Conical Connection TiUltra™ RP 4.3x18mm · 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 has 438 adverse event reports, with 431 injuries and no deaths. The reports mostly describe the implant failing to osseointegrate, meaning it does not bond with the bone, and some describe a lack of stability during placement or implant fracture. 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
- 442
- Deaths reported
- 0
- Injuries reported
- 435
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 442 adverse event reports that list this exact device (DI 07332747128000), received between Oct 29, 2021 and Sep 17, 2026 — classified as 435 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (328 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 Osseointegrate328
- Loss of Osseointegration56
- Osseointegration Problem24
- Fracture16
- Adverse Event Without Identified Device or Use Problem4
- Premature Separation4
- Difficult to Insert2
- Malposition of Device2
Patient problems
- Failure of Implant294
- No Clinical Signs, Symptoms or Conditions100
- Unspecified Infection34
- Pain32
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Inflammation6
- Implant Pain4
- Numbness2
Recent adverse event reports
The 25 most recent of 442 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 50811455 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811450 ↗InjuryAug 20, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50357106 ↗InjuryAug 20, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50357104 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50014308 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50014307 ↗InjuryJul 4, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711343 ↗InjuryJul 4, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711342 ↗InjuryJul 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25699373 ↗InjuryJul 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25699372 ↗InjuryJun 30, 2026Failure to Osseointegrate
InjuryJun 30, 2026Failure to Osseointegrate
InjuryJun 26, 2026Loss of Osseointegration
InjuryJun 26, 2026Loss of Osseointegration
InjuryMay 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25194318 ↗InjuryMay 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25193223 ↗InjuryMay 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133083 ↗InjuryMay 9, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133081 ↗InjuryMay 7, 2026Failure to Osseointegrate
InjuryMay 7, 2026Failure to Osseointegrate
InjuryMay 7, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117757 ↗InjuryMay 7, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117747 ↗InjuryMay 7, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117739 ↗InjuryMay 7, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117738 ↗InjuryApr 23, 2026Failure to Osseointegrate
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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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