XiVE® 32262415Recalls & reported problems
Dentsply Implants Manufacturing GmbH · XiVE® S plus Implant D3.0/L15 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply XiVE dental implant sits in the jaw to hold replacement teeth. Reports mostly describe implants that never bonded with the bone or loosened later and had to be removed, sometimes with bone loss and infection. There are 23 reports naming its identifier, mentioning 23 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
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07392532208782), received between Jun 19, 2023 and Aug 12, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (13 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 Osseointegrate13
- Loss of Osseointegration10
- Off-Label Use2
- Mechanical Problem1
- Separation Failure1
Patient problems
- Failure of Implant23
- Osteolysis8
- Unspecified Infection6
- Pocket Erosion4
- Inflammation2
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss due to progressive bone loss.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 50223631 ↗InjuryAug 12, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. And also reported was Osteolysis.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 50220409 ↗InjuryJul 1, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25679229 ↗InjuryApr 1, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO PROGRESSIVE BONE LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 24759143 ↗InjuryNov 20, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED OSTEOLYSIS AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 23603181 ↗InjuryJan 3, 2025Off-Label Use; Loss of Osseointegration; Off-Label Use; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion
MAUDE report 21067104 ↗InjuryDec 12, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 20917225 ↗InjuryDec 12, 2024Off-Label Use; Loss of Osseointegration; Off-Label Use; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 20913367 ↗InjuryOct 30, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion
MAUDE report 20566185 ↗InjuryAug 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19939477 ↗InjuryApr 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19173913 ↗InjuryApr 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19172362 ↗InjuryMar 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18985209 ↗InjuryFeb 22, 2024Failure 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 18757836 ↗InjuryJan 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18452604 ↗InjuryJan 5, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18451953 ↗InjuryJan 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18443982 ↗InjuryDec 8, 2023Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18293369 ↗InjuryJul 6, 2023Mechanical Problem; Failure to Osseointegrate; Separation Failure; Mechanical Problem; Failure to Osseointegrate; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 17265940 ↗InjuryJul 6, 2023Failure 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 17265918 ↗InjuryJul 5, 2023Failure 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 17255466 ↗InjuryJun 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion; Unspecified Infection
MAUDE report 17152062 ↗InjuryJun 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Pocket Erosion
MAUDE report 17151902 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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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