DS PrimeTaperRecalls & reported problems across all models
Dentsply Implants Manufacturing GmbH · 61 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6,897
- Deaths reported
- 0
- Injuries reported
- 6,856
- Recalls
- 0
We found 61 models of DS PrimeTaper by Dentsply Implants Manufacturing GmbH in the FDA's device registry (GUDID). Together they are named in 6,897 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2023 and Sep 30, 2026 — classified as 6,856 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (5,705 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 PrimeTaper problems
Device problems
- Failure to Osseointegrate5,705
- Loss of Osseointegration983
- Insufficient Device Problem Information49
- Fracture47
- Malposition of Device36
- Off-Label Use34
- Material Deformation30
- Adverse Event Without Identified Device or Use Problem25
Patient problems
- Failure of Implant6,659
- Unspecified Infection1,495
- Osteolysis516
- Inflammation460
- Pocket Erosion300
- Inadequate Osseointegration109
- No Clinical Signs, Symptoms or Conditions107
- Implant Pain93
DS PrimeTaper models
61 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DS PrimeTaper 68011092IMPLANT, ENDOSSEOUS, ROOT-FORM917 reports
- DS PrimeTaper 68011091IMPLANT, ENDOSSEOUS, ROOT-FORM712 reports
- DS PrimeTaper 68011098IMPLANT, ENDOSSEOUS, ROOT-FORM710 reports
- DS PrimeTaper 68011099IMPLANT, ENDOSSEOUS, ROOT-FORM699 reports
- DS PrimeTaper 68011097IMPLANT, ENDOSSEOUS, ROOT-FORM375 reports
- DS PrimeTaper 68011105IMPLANT, ENDOSSEOUS, ROOT-FORM342 reports
- DS PrimeTaper 68011093IMPLANT, ENDOSSEOUS, ROOT-FORM324 reports
- DS PrimeTaper 68011090IMPLANT, ENDOSSEOUS, ROOT-FORM279 reports
- DS PrimeTaper 68011100IMPLANT, ENDOSSEOUS, ROOT-FORM249 reports
- DS PrimeTaper 68011106IMPLANT, ENDOSSEOUS, ROOT-FORM235 reports
- DS PrimeTaper 68011104IMPLANT, ENDOSSEOUS, ROOT-FORM232 reports
- DS PrimeTaper 68011098IMPLANT, ENDOSSEOUS, ROOT-FORM194 reports
- DS PrimeTaper 68011099IMPLANT, ENDOSSEOUS, ROOT-FORM182 reports
- DS PrimeTaper 68011096IMPLANT, ENDOSSEOUS, ROOT-FORM129 reports
- DS PrimeTaper 68011103IMPLANT, ENDOSSEOUS, ROOT-FORM102 reports
- DS PrimeTaper 68011105IMPLANT, ENDOSSEOUS, ROOT-FORM99 reports
- DS PrimeTaper 68011087IMPLANT, ENDOSSEOUS, ROOT-FORM90 reports
- DS PrimeTaper 68011112IMPLANT, ENDOSSEOUS, ROOT-FORM77 reports
- DS PrimeTaper 68011093IMPLANT, ENDOSSEOUS, ROOT-FORM73 reports
- DS PrimeTaper 68011097IMPLANT, ENDOSSEOUS, ROOT-FORM70 reports
- DS PrimeTaper 68011104IMPLANT, ENDOSSEOUS, ROOT-FORM64 reports
- DS PrimeTaper 68011106IMPLANT, ENDOSSEOUS, ROOT-FORM64 reports
- DS PrimeTaper 68011086IMPLANT, ENDOSSEOUS, ROOT-FORM60 reports
- DS PrimeTaper 68011100IMPLANT, ENDOSSEOUS, ROOT-FORM59 reports
- DS PrimeTaper 68011113IMPLANT, ENDOSSEOUS, ROOT-FORM56 reports
- DS PrimeTaper 68011094IMPLANT, ENDOSSEOUS, ROOT-FORM55 reports
- DS PrimeTaper 68011101IMPLANT, ENDOSSEOUS, ROOT-FORM55 reports
- DS PrimeTaper 68011111IMPLANT, ENDOSSEOUS, ROOT-FORM49 reports
- DS PrimeTaper 68011107IMPLANT, ENDOSSEOUS, ROOT-FORM46 reports
- DS PrimeTaper 68011088IMPLANT, ENDOSSEOUS, ROOT-FORM41 reports
- DS PrimeTaper 68011110IMPLANT, ENDOSSEOUS, ROOT-FORM34 reports
- DS PrimeTaper 68011096IMPLANT, ENDOSSEOUS, ROOT-FORM25 reports
- DS PrimeTaper 68011094IMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- DS PrimeTaper 68011112IMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
- DS PrimeTaper 68011111IMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- DS PrimeTaper 68011085IMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
- DS PrimeTaper 68011087IMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- DS PrimeTaper 68011107IMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- DS PrimeTaper 68011108IMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- DS PrimeTaper 68011103IMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- DS PrimeTaper 68011113IMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- DS PrimeTaper 68017259Accessories, implant, dental, endosseous7 reports
- DS PrimeTaper 68011089IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- DS PrimeTaper 68017257Accessories, implant, dental, endosseous6 reports
- DS PrimeTaper 68017260Accessories, implant, dental, endosseous6 reports
- DS PrimeTaper 68011095IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- DS PrimeTaper 68011102IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- DS PrimeTaper 68011114IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- DS PrimeTaper 68011101IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- DS PrimeTaper 68011088IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- DS PrimeTaper 68017255Accessories, implant, dental, endosseous4 reports
- DS PrimeTaper 68011086IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- DS PrimeTaper 68011095IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- DS PrimeTaper 68017258Accessories, implant, dental, endosseous3 reports
- DS PrimeTaper 68017266Accessories, implant, dental, endosseous3 reports
- DS PrimeTaper 68011108IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- DS PrimeTaper 68011114IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- DS PrimeTaper 68017256Accessories, implant, dental, endosseous2 reports
- DS PrimeTaper 68011115IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- DS PrimeTaper 68011109IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- DS PrimeTaper 68011115IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent DS PrimeTaper adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50955068 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Osteolysis; Unspecified Infection
MAUDE report 50955029 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954894 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50954825 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954818 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954771 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954692 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954659 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50953219 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50952870 ↗MalfunctionSep 30, 2026Manufacturing, Packaging or Shipping Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952609 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50952433 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951885 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Unspecified Infection
MAUDE report 50951786 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951507 ↗
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 OmniTaper32 models · 2,128 reports
- DS Implants44 models · 145 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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