DS PrimeTaper 68011087 (UDI 07392532270086)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø3.0 x 11mm OsseoSpeed · Class 2 · Implant
All models of DS PrimeTaper (61)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07392532270086), received between Sep 20, 2024 and Mar 25, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (15 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 Osseointegrate15
- Off-Label Use3
Patient problems
- Failure of Implant15
- Unspecified Infection6
- Osteolysis1
- Pocket Erosion1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN UNSPECIFIED INFECTION AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24683794 ↗InjuryMar 14, 2026Failure to Osseointegrate
CUSTOMER REPORTED IMPLANT LOSS. (B)(6). FAILURE TO INTEGRATE. PT RETURNED FOR 3 WEEKS FOLLOW-UP REPORTED IMPLANT FELT LOOSE. HE EXPLAINED HE WEARS A RETAINER AT NIGHT THAT ORTHODONTIST SAID MUST BE WORN TO PREVENT RELAPSE OF PALATAL EXPANSION. PT. REPORTED THAT FIRST FEW NICHTS AFTER IMPLANT, RETAINER WOULDN'T FULLY SEAT. PT THEN "FORCED" IT IN AFTER A FEW NIGHTS AND FELT THAT IT WAS PUTTING A LOT OF PRESSURE ON THE IMPLANT TEMP CROWN.
Patient problems: Failure of Implant
MAUDE report 24601424 ↗InjuryJan 14, 2026Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED OSTEOLYSIS AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24064488 ↗InjuryOct 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED IMPLANT LOOSENING AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23331575 ↗InjuryJul 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22672798 ↗InjuryJul 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22386255 ↗InjuryMay 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22023321 ↗InjuryMar 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21701308 ↗InjuryMar 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21678242 ↗InjuryMar 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21617318 ↗InjuryDec 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21034809 ↗InjuryNov 19, 2024Off-Label Use; Failure to Osseointegrate; Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20722414 ↗InjuryOct 11, 2024Off-Label Use; Failure to Osseointegrate; Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion
MAUDE report 20426566 ↗InjurySep 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20266306 ↗InjurySep 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 20266285 ↗
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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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