DS PrimeTaper 68011098 (UDI 07392532258688)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø4.2 x 9mm 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 implant has 194 reports, 193 injuries and no deaths. Nearly all describe the implant failing to bond with the bone, often leading to the implant being lost, and some mention infection or bone loss around it. Reports fell from 80 in the prior 12 months to 17 in the most recent 12 months. 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
- 194
- Deaths reported
- 0
- Injuries reported
- 193
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 07392532258688), received between Jul 5, 2023 and Apr 23, 2026 — classified as 193 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (166 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 Osseointegrate166
- Loss of Osseointegration24
- Insufficient Device Problem Information2
- Material Deformation2
- Fracture1
- Malposition of Device1
- Mechanical Problem1
- Migration or Expulsion of Device1
Patient problems
- Failure of Implant193
- Unspecified Infection37
- Pocket Erosion18
- Osteolysis13
- Inflammation11
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- Sinus Perforation1
Recent adverse event reports
The 25 most recent of 194 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Material Deformation
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24961933 ↗InjuryApr 23, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED PROGRESSIVE BONE LOSS (OSTEOLYSIS) AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24961885 ↗InjuryApr 21, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN IMPLANT MOBILITY ISSUE AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24934568 ↗InjuryApr 7, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24812247 ↗InjuryMar 25, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24683937 ↗InjuryMar 8, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT HAD "SOFT BONE" WHICH ALLEGEDLY ATTRIBUTED TO A DENTAL IMPLANT LOSS. IT WAS REPORTED THEY ALSO HAD AN UNSPECIFIED INFECTION, PERIIMPLANTITIS, AND IMPLANT MOBILITY ISSUES.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 24542132 ↗InjuryFeb 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24361903 ↗InjuryJan 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24064479 ↗InjuryDec 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT MOBILITY ISSUE AND IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23931600 ↗InjuryNov 25, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23648246 ↗InjuryNov 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 23614375 ↗InjuryNov 20, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN UNSPECIFIC INFECTION AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 23603195 ↗InjuryNov 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23563488 ↗InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23552545 ↗InjuryNov 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23552524 ↗InjuryNov 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 23531266 ↗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 23529051 ↗InjuryOct 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 23433600 ↗InjuryOct 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 23433598 ↗InjuryOct 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 23433597 ↗InjuryOct 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 23433594 ↗InjuryOct 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 23433588 ↗InjuryOct 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 23331596 ↗InjuryOct 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 23331538 ↗InjuryOct 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 23319983 ↗
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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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