DS PrimeTaper 68011112 (UDI 07392532276859)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø5.4 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 EV endosseous dental implant is a root-form screw placed into the jawbone to replace a tooth. The 73 reports mostly describe implants that failed to fuse with the bone and were later lost, often alongside infection, bone breakdown (osteolysis), inflammation, and gum erosion. There are 73 injuries and no deaths. 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
- 77
- Deaths reported
- 0
- Injuries reported
- 77
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 07392532276859), received between Jun 30, 2023 and Sep 30, 2026 — classified as 77 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (63 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 Osseointegrate63
- Loss of Osseointegration9
- Fracture2
- Malposition of Device2
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant73
- Unspecified Infection21
- Osteolysis13
- Inflammation10
- Inadequate Osseointegration4
- Pocket Erosion4
- Discomfort1
- Implant Pain1
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50943963 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50937134 ↗InjurySep 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50931712 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50775206 ↗InjuryAug 13, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50234403 ↗InjuryAug 6, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50157030 ↗InjuryAug 3, 2026Fracture
It was reported that the patient experienced a fracture of the dental implant, which resulted in implant loss and progressive bone loss.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 50111822 ↗InjuryJul 31, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50096510 ↗InjuryJul 9, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. AN INFECTION WAS ALSO REPORTED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25773440 ↗InjuryJun 22, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH PROGRESSIVE BONE LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25576936 ↗InjuryMay 28, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. THE PATIENT ALSO REPORTED THAT THEY HAD INFLAMMATION AND OSTEOLYSIS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 25316862 ↗InjuryApr 20, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24931870 ↗InjuryApr 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24911403 ↗InjuryApr 7, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24799221 ↗InjuryFeb 16, 2026Failure to Osseointegrate
InjuryFeb 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24334775 ↗InjuryFeb 13, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24332289 ↗InjuryFeb 3, 2026Loss of Osseointegration
CUSTOMER REPORTED IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24248073 ↗InjuryFeb 3, 2026Failure to Osseointegrate
CUSTOMER REPORTED IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 24247662 ↗InjuryJan 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 24101268 ↗InjuryJan 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 24092997 ↗InjuryDec 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 23821943 ↗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 23585894 ↗InjuryOct 29, 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 23416281 ↗InjuryOct 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 23365822 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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