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NobelParallel™ 37984 (UDI 07332747161397)Recalls & reported problems

Nobel Biocare AB · NobelParallel™ Conical Connection WP 5.5x7mm · Class 2 · Implant

Quick summary

This Nobel Biocare NobelParallel implant, placed into bone, has 337 reports, 336 of them injuries and no deaths. The reports mostly describe the implant losing its bond with the surrounding bone or never forming one, and some patients reporting infection, pain or abscess. 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
343
Deaths reported
0
Injuries reported
342
Recalls naming it
0

Summary

The FDA's MAUDE database contains 343 adverse event reports that list this exact device (DI 07332747161397), received between Nov 1, 2021 and Sep 19, 2026 — classified as 342 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (198 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

Nov 2023: 6 reportsDec 2023: 4 reportsJan 2024: 6 reportsFeb 2024: 4 reportsMar 2024: 2 reportsApr 2024: 4 reportsMay 2024: 8 reportsJun 2024: 12 reportsJul 2024: 14 reportsAug 2024: 4 reportsSep 2024: 4 reportsOct 2024: 7 reportsNov 2024: 4 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 14 reportsMar 2025: 10 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 38 reportsAug 2025: 10 reportsSep 2025: 4 reportsOct 2025: 0 reportsNov 2025: 6 reportsDec 2025: 6 reportsJan 2026: 4 reportsFeb 2026: 8 reportsMar 2026: 4 reportsApr 2026: 16 reportsMay 2026: 4 reportsJun 2026: 5 reportsJul 2026: 2 reportsAug 2026: 2 reportsSep 2026: 4 reportsOct 2026: 0 reports20242025202638
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate198
  • Loss of Osseointegration83
  • Osseointegration Problem38
  • Patient Device Interaction Problem12
  • Difficult to Insert4
  • Activation, Positioning or Separation Problem2
  • Adverse Event Without Identified Device or Use Problem2
  • Insufficient Device Problem Information2

Patient problems

  • Failure of Implant216
  • No Clinical Signs, Symptoms or Conditions95
  • Pain26
  • Unspecified Infection24
  • Abscess6
  • Numbness6
  • Implant Pain4
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2

Recent adverse event reports

The 25 most recent of 343 reports, in the reporter's own words as published by the FDA.

  • InjurySep 19, 2026Loss of Osseointegration

    Patient problems: Unspecified Infection

    MAUDE report 50833278 ↗
  • InjurySep 19, 2026Loss of Osseointegration

    Patient problems: Unspecified Infection

    MAUDE report 50833275 ↗
  • InjurySep 16, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50795741 ↗
  • InjurySep 16, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50795736 ↗
  • InjuryAug 19, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50331555 ↗
  • InjuryAug 19, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50331553 ↗
  • InjuryJul 15, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 25832305 ↗
  • InjuryJul 15, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 25832205 ↗
  • InjuryJun 13, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25496598 ↗
  • InjuryJun 10, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25463844 ↗
  • InjuryJun 10, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25463843 ↗
  • InjuryJun 10, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25463811 ↗
  • InjuryJun 10, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25463794 ↗
  • InjuryMay 21, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25248788 ↗
  • InjuryMay 21, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25248784 ↗
  • InjuryMay 7, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25118434 ↗
  • InjuryMay 7, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25118433 ↗
  • InjuryApr 29, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25036871 ↗
  • InjuryApr 29, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25036854 ↗
  • InjuryApr 28, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25023235 ↗
  • InjuryApr 28, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25022903 ↗
  • InjuryApr 17, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24917548 ↗
  • InjuryApr 17, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24917526 ↗
  • InjuryApr 17, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Unspecified Infection

    MAUDE report 24917470 ↗
  • InjuryApr 17, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Unspecified Infection

    MAUDE report 24917463 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.