DS PrimeTaper 68011113 (UDI 07392532276866)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø5.4 x 11mm OsseoSpeed · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply PrimeTaper endosseous dental implant is a root-form screw placed into the jaw to hold a tooth replacement. Most of the 57 reports describe implants that never fused properly with the bone or later lost that fusion, so the implant had to be removed; reports also mention infections and gum/bone breakdown around the site. There are 56 injuries and no deaths, and no recalls 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
- 56
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 07392532276866), received between Jul 12, 2023 and Aug 17, 2026 — classified as 55 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (44 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate44
- Loss of Osseointegration7
- Material Deformation2
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Malposition of Device1
Patient problems
- Failure of Implant56
- Unspecified Infection16
- Osteolysis3
- Pocket Erosion3
- Implant Pain2
- Inflammation2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Material Deformation
Patient problems: Failure of Implant
MAUDE report 50273659 ↗InjuryJul 30, 2026Material Deformation
It was reported that a scan body issue occurred. The customer reported being unable to fully seat the Atlantis scan body due to interference at the implant-abutment interface.The implant was placed and buried, then uncovered three months later for placement of a healing abutment. Reverse torque testing demonstrated implant stability at 30 Ncm, and the patient reported no pain.Multiple attempts were made to seat the scan body; however, it could not be fully seated. Periapical radiographs were obtained, and the patient returned for a follow-up appointment with the sales representative. Additional intraoral photographs and periapical radiographs were taken. Based on the clinical and radiographic evaluation, a defect at the base of the implant was identified, preventing the scan body from fully seating. The customer was advised to remove the implant, perform bone grafting, and replace the implant.
Patient problems: Failure of Implant
MAUDE report 50089560 ↗InjuryJul 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25856271 ↗InjuryJul 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25824661 ↗InjuryJul 14, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25813379 ↗InjuryJun 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25520999 ↗InjuryMay 15, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25183240 ↗InjuryMay 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25055997 ↗InjuryApr 20, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24925351 ↗InjuryApr 13, 2026Failure to Osseointegrate
CUSTOMER REPORTED AN IMPLANT LOSS "IMPLANT FAILED TO INTEGRATE". PRODUCT PENDING.
Patient problems: Failure of Implant
MAUDE report 24859069 ↗InjuryApr 2, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO INFECTION AND MOBILITY.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24770061 ↗InjuryMar 23, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24665298 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED SURGICAL ISSUE SF - (B)(4). IT HAD REMAINS MARILLAS TEETH REVERED FOR FULL ARCH RECONSTRUTO MO STRATEGY AT #14-GRAFTED FOR LATER PLACEMENT.
Patient problems: Failure of Implant
MAUDE report 24651421 ↗InjuryMar 20, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 24648829 ↗InjuryMar 14, 2026Failure to Osseointegrate
CUSTOMER REPORTED IMPLANT LOSS. INFECTION DURING INTEGRATION PERIOD- REMOVED IMPLANT.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24600837 ↗InjuryMar 5, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24525129 ↗InjuryFeb 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24338287 ↗InjuryJan 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24071188 ↗InjuryJan 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24020703 ↗InjuryDec 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23756359 ↗InjuryDec 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23724583 ↗InjuryNov 18, 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 23589482 ↗InjuryNov 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 23585934 ↗InjuryNov 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23525815 ↗InjuryNov 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23525796 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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