DS PrimeTaper 68011100 (UDI 07392532276736)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · PrimeTaper EV Ø4.2 x 13mm OsseoSpeed · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply PrimeTaper implant is a dental implant placed into bone. Reports most often describe the implant failing to bond with the bone and being lost, with some mentioning infection and bone loss around it. The database holds 243 reports, including no deaths and 241 injuries, with 2 malfunctions. No recalls name this device, and reports rose over the last year (101) compared with the year before (43).
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
- 249
- Deaths reported
- 0
- Injuries reported
- 247
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 249 adverse event reports that list this exact device (DI 07392532276736), received between Jun 27, 2023 and Sep 18, 2026 — classified as 247 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (187 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 Osseointegrate187
- Loss of Osseointegration55
- Adverse Event Without Identified Device or Use Problem2
- Fracture2
- Difficult to Insert1
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
- Overfill1
Patient problems
- Failure of Implant243
- Unspecified Infection73
- Osteolysis24
- Inflammation18
- Pocket Erosion12
- Inadequate Osseointegration4
- Implant Pain3
- Abscess2
Recent adverse event reports
The 25 most recent of 249 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50830615 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50830490 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration
MAUDE report 50830063 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50787224 ↗InjurySep 16, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50785898 ↗InjuryAug 14, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50253519 ↗InjuryAug 12, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50227086 ↗InjuryAug 10, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50193802 ↗InjuryAug 10, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50190190 ↗InjuryAug 6, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50154713 ↗InjuryAug 3, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50111095 ↗InjuryJul 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection and inflammation.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 50085376 ↗InjuryJul 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection and inflammation.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 50058192 ↗InjuryJul 16, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH AN INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25843247 ↗InjuryJul 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 25817491 ↗InjuryJul 7, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25739365 ↗InjuryJul 7, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25734165 ↗InjuryJul 7, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25734013 ↗InjuryJul 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25718402 ↗InjuryJul 4, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25710350 ↗InjuryJul 4, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25709658 ↗InjuryJul 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25680333 ↗InjuryJul 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25678423 ↗InjuryJul 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25678418 ↗InjuryJun 30, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25666358 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
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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 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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