Ditron Dental ULT-11500Recalls & reported problems
Ditron Dental Ltd · Ultimate Precision Implant Ø5.0mm L11.5mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07290109280653), received between Aug 19, 2024 and Jun 21, 2026 — classified as 13 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (7 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration7
- Failure to Osseointegrate5
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inadequate Osseointegration12
- Unspecified Infection1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2026Failure to Osseointegrate
InjuryJan 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 12, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20910826 ↗InjuryDec 5, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20851223 ↗InjuryNov 28, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20804084 ↗InjuryNov 28, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20804074 ↗InjuryNov 21, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20742956 ↗InjuryOct 13, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20435737 ↗InjuryOct 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE, THE IMPLANT FELL DOWN.
Patient problems: Inadequate Osseointegration
MAUDE report 20414892 ↗InjurySep 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 21, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20011059 ↗InjuryAug 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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