DS ImplantsRecalls & reported problems across all models
Dentsply Implants Manufacturing GmbH · 44 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 145
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls
- 0
We found 44 models of DS Implants by Dentsply Implants Manufacturing GmbH in the FDA's device registry (GUDID). Together they are named in 145 adverse event reports in the FDA's MAUDE database, received between Jan 25, 2024 and Sep 30, 2026 — classified as 54 injuries, 91 malfunctions.
The most frequently reported specific device problem is “Fracture” (78 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DS Implants problems
Device problems
- Fracture78
- Mechanical Problem26
- Separation Failure26
- Insufficient Device Problem Information6
- Failure to Osseointegrate4
- Material Deformation4
- Loose or Intermittent Connection3
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions94
- Failure of Implant39
- Insufficient Information10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Aspiration/Inhalation1
- Foreign Body In Patient1
- Hypersensitivity/Allergic reaction1
DS Implants models
44 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DS Implants 68017001Accessories, implant, dental, endosseous33 reports
- DS Implants 68017002Accessories, implant, dental, endosseous19 reports
- DS Implants 68017003Accessories, implant, dental, endosseous15 reports
- DS Implants 68015197Accessories, implant, dental, endosseous11 reports
- DS Implants 68015205Accessories, implant, dental, endosseous4 reports
- DS Implants 68013007Abutment, implant, dental, endosseous4 reports
- DS Implants 68013025Abutment, implant, dental, endosseous4 reports
- DS Implants 68012194Abutment, implant, dental, endosseous4 reports
- DS Implants 68012168Abutment, implant, dental, endosseous3 reports
- DS Implants 68012233Abutment, implant, dental, endosseous3 reports
- DS Implants 68010005Abutment, implant, dental, endosseous2 reports
- DS Implants 68012166Abutment, implant, dental, endosseous2 reports
- DS Implants 68013016Abutment, implant, dental, endosseous2 reports
- DS Implants 68013024Abutment, implant, dental, endosseous2 reports
- DS Implants 68013028Abutment, implant, dental, endosseous2 reports
- DS Implants 68013029Abutment, implant, dental, endosseous2 reports
- DS Implants 68012079Abutment, implant, dental, endosseous2 reports
- DS Implants 68012169Abutment, implant, dental, endosseous2 reports
- DS Implants 68012175Abutment, implant, dental, endosseous2 reports
- DS Implants 68012195Abutment, implant, dental, endosseous2 reports
- DS Implants 68012211Abutment, implant, dental, endosseous2 reports
- DS Implants 68015134Accessories, implant, dental, endosseous1 report
- DS Implants 68010002Abutment, implant, dental, endosseous1 report
- DS Implants 68010006Abutment, implant, dental, endosseous1 report
- DS Implants 68014014Accessories, implant, dental, endosseous1 report
- DS Implants 68013005Abutment, implant, dental, endosseous1 report
- DS Implants 68013029Abutment, implant, dental, endosseous1 report
- DS Implants 68013050Abutment, implant, dental, endosseous1 report
- DS Implants 68012078Abutment, implant, dental, endosseous1 report
- DS Implants 68015207Accessories, implant, dental, endosseous1 report
- DS Implants 68013070Abutment, implant, dental, endosseous1 report
- DS Implants 68010002Abutment, implant, dental, endosseous1 report
- DS Implants 68010005Abutment, implant, dental, endosseous1 report
- DS Implants 68010006Abutment, implant, dental, endosseous1 report
- DS Implants 68013011Abutment, implant, dental, endosseous1 report
- DS Implants 68013015Abutment, implant, dental, endosseous1 report
- DS Implants 68013017Abutment, implant, dental, endosseous1 report
- DS Implants 68013020Abutment, implant, dental, endosseous1 report
- DS Implants 68012179Abutment, implant, dental, endosseous1 report
- DS Implants 68012180Abutment, implant, dental, endosseous1 report
- DS Implants 68012207Abutment, implant, dental, endosseous1 report
- DS Implants 68012210Abutment, implant, dental, endosseous1 report
- DS Implants 68013066Abutment, implant, dental, endosseous1 report
- DS Implants 68017286Accessories, implant, dental, endosseous1 report
Recent DS Implants adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952426 ↗MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934300 ↗MalfunctionSep 28, 2026Separation Failure
It was reported that there was a malfunction where the abutment is stuck to the implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916941 ↗InjurySep 24, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890300 ↗MalfunctionSep 24, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890146 ↗MalfunctionSep 24, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889915 ↗MalfunctionSep 21, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847575 ↗MalfunctionSep 18, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820736 ↗MalfunctionSep 9, 2026Fracture
Patient problems: Insufficient Information
MAUDE report 50690738 ↗MalfunctionSep 4, 2026Fracture
It was reported that the Implant Driver PEEK tip broke during use. No injury resulted.
Patient problems: Insufficient Information
MAUDE report 50611094 ↗InjuryAug 6, 2026Fracture
It was reported that the implant driver tip fractured, allegedly resulting in abortion of the surgery.
Patient problems: Failure of Implant
MAUDE report 50158307 ↗InjuryJul 29, 2026Fracture
It was reported that a patient experienced a dental implant fracture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50067220 ↗InjuryJul 29, 2026Fracture
It was reported that a patient experienced a dental implant fracture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50067217 ↗MalfunctionJul 15, 2026Fracture
IT WAS REPORTED THAT THERE WAS A TOOL ISSUE: THE IMPLANT DRIVER TIP WAS BROKEN. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25830996 ↗MalfunctionJul 15, 2026Mechanical Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A TOOL MALFUNCTION WHERE THE DRILL BIT NO LONGER STAYS IN THE SHANK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825611 ↗
Other Dentsply Implants Manufacturing GmbH products
- ASTRA TECH Implant System EV177 models · 37,200 reports
- ASTRA TECH Implant System166 models · 27,749 reports
- ANKYLOS112 models · 20,917 reports
- XiVE62 models · 12,456 reports
- DS PrimeTaper61 models · 6,897 reports
- DS OmniTaper32 models · 2,128 reports
- FRIADENT23 models · 55 reports
- FRIALIT12 models · 35 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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