DS PrimeTaper 68011106 (UDI 07392532258763)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø4.8 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 endosseous dental implant is a screw-shaped implant placed in the jawbone. Most of the 64 reports describe implants that failed to fuse with the bone or that lost that fusion, along with infection, erosion of the gum pocket, and bone breakdown; all 64 were injuries and no deaths were reported. There are no recalls naming this device. Reports have dropped sharply, from 36 in the earlier 12 months to 3 in the most recent 12 months.
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
- 64
- Deaths reported
- 0
- Injuries reported
- 64
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 07392532258763), received between Nov 8, 2023 and Apr 17, 2026 — classified as 64 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (59 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 Osseointegrate59
- Loss of Osseointegration5
Patient problems
- Failure of Implant64
- Unspecified Infection21
- Pocket Erosion7
- Osteolysis3
- Inflammation2
- Swelling/ Edema1
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24913193 ↗InjuryDec 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED BUCAL BONE LOSS, GRAFT FAILURE, AND IMPLANT REMOVED DUE TO EXPOSED THREADS AND UNSPECIFIED INFECTION.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 23824934 ↗InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS AND UNSPECIFIC INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 23603019 ↗InjuryAug 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22880499 ↗InjuryAug 11, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 22779895 ↗InjuryJul 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DOUBLE DENTAL IMPLANT LOSS DURING HEALING PHASE - NAVIGATED IMPLANTATION. AFTER A FEW DAYS CRESTAL AROUND BOTH IMPLANTS HAD SLIGHT SIGNS OF INFLAMMATION; IMPROVEMENT AFTER EXPLANTATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22584393 ↗InjuryJul 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DOUBLE DENTAL IMPLANT LOSS DURING HEALING PHASE - NAVIGATED IMPLANTATION. AFTER A FEW DAYS CRESTAL AROUND BOTH IMPLANTS HAD SLIGHT SIGNS OF INFLAMMATION; IMPROVEMENT AFTER EXPLANTATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22584391 ↗InjuryJul 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22542867 ↗InjuryJul 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22542852 ↗InjuryJul 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 22500834 ↗InjuryJul 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 22500453 ↗InjuryJul 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22490170 ↗InjuryJul 7, 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 22420736 ↗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 22381275 ↗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 22381256 ↗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 22380457 ↗InjuryJun 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 22318303 ↗InjuryJun 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22303953 ↗InjuryJun 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22299521 ↗InjuryJun 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Pocket Erosion; Unspecified Infection
MAUDE report 22236105 ↗InjuryJun 15, 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 22208737 ↗InjuryJun 7, 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 22164000 ↗InjuryJun 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22160034 ↗InjuryJun 5, 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 22150870 ↗InjuryJun 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22132443 ↗
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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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