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Ditron Dental ULT-16420Recalls & reported problems

Ditron Dental Ltd · Ultimate Precision Implant Ø4.20mm L16mm · Class 2 · Implant

Adverse event reports
9
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07290109280721), received between Jul 14, 2024 and Jul 30, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (6 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: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 3 reportsNov 2024: 1 reportsDec 2024: 1 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Loss of Osseointegration6
  • Failure to Osseointegrate2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Inadequate Osseointegration8
  • Unspecified Infection1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 30, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Inadequate Osseointegration

    MAUDE report 22661817 ↗
  • InjuryJan 9, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Inadequate Osseointegration

    MAUDE report 21109007 ↗
  • InjuryJan 2, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.

    Patient problems: Inadequate Osseointegration

    MAUDE report 21052656 ↗
  • InjuryDec 12, 2024Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.

    Patient problems: Inadequate Osseointegration

    MAUDE report 20911142 ↗
  • InjuryNov 21, 2024Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.

    Patient problems: Inadequate Osseointegration

    MAUDE report 20743040 ↗
  • InjuryOct 10, 2024Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.

    Patient problems: Inadequate Osseointegration

    MAUDE report 20414909 ↗
  • InjuryOct 6, 2024Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.

    Patient problems: Inadequate Osseointegration

    MAUDE report 20379677 ↗
  • InjuryOct 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 20379671 ↗
  • InjuryJul 14, 2024Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Inadequate Osseointegration

    MAUDE report 19737362 ↗

Other Implant, Endosseous, Root-Form devices

All Implant, Endosseous, Root-Form devices →

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