DS PrimeTaper 68011099 (UDI 07392532276729)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø4.2 x 11mm OsseoSpeed · Class 2 · Implant
All models of DS PrimeTaper (61)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply PrimeTaper dental implant appears in 674 adverse event reports, with no deaths and 674 injuries. Reports mostly describe the implant failing to fuse with the jawbone or losing that bond, with some noting infection and bone loss around the implant. Reports rose over the last 12 months, to 303 from 155 in the 12 months before, and there are no recalls that name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 699
- Deaths reported
- 0
- Injuries reported
- 698
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 699 adverse event reports that list this exact device (DI 07392532276729), received between Jun 21, 2023 and Sep 30, 2026 — classified as 698 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (579 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
- Failure to Osseointegrate579
- Loss of Osseointegration107
- Fracture4
- Material Deformation4
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
- Malposition of Device2
- Mechanical Problem2
Patient problems
- Failure of Implant671
- Unspecified Infection171
- Osteolysis55
- Inflammation41
- Pocket Erosion25
- Inadequate Osseointegration14
- Implant Pain11
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 25 most recent of 699 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50953219 ↗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: Inadequate Osseointegration
MAUDE report 50943908 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with occlusal overload.
Patient problems: Inadequate Osseointegration
MAUDE report 50917266 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913438 ↗MalfunctionSep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a fit issue occurred.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854084 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829267 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50796927 ↗InjurySep 16, 2026Malposition of Device
It was reported that a bone lamella fracture occurred during implant placement.
Patient problems: Periprosthetic fracture
MAUDE report 50787889 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50781961 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Osteolysis
MAUDE report 50781867 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50781756 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50781727 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50781623 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50781596 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50781525 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50776573 ↗InjurySep 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50757263 ↗InjurySep 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss- infection, periimplantitis
Patient problems: Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50720833 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695030 ↗InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694201 ↗InjurySep 8, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50674926 ↗InjurySep 8, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671989 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50656390 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. No patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479073 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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