DS Implants 68013025Recalls & reported problems
Dentsply Implants Manufacturing GmbH · HealDesign EV (L) Ø5.0 4.5mm · Class 2 · Implant
All models of DS Implants (44)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07392532277634), received between Jul 16, 2025 and Feb 22, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (2 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
- Separation Failure2
- Fracture1
- Material Deformation1
Patient problems
- Failure of Implant2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 22, 2026Separation Failure
IT WAS REPORTED THAT THE HEALING ABUTMENT WAS STUCK.
Patient problems: Insufficient Information
MAUDE report 24410524 ↗MalfunctionFeb 7, 2026Material Deformation
IT WAS REPORTED THAT A PATIENT EXPERIENCED A STRIPPED HEALING ABUTMENT. THE ABUTMENT WAS REMOVED, AND THE IMPLANT IS LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24285979 ↗InjuryJan 29, 2026Fracture
IT WAS REPORTED THAT A PATIENT HAD A STRIPPED ABUTMENT.
Patient problems: Failure of Implant
MAUDE report 24208012 ↗InjuryJul 16, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22519327 ↗
Other Abutment, implant, dental, endosseous devices
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- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Straumann Anatomic Healing Abutments XC (AHA) Healing ComponentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 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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