XiVE® 32262423Recalls & reported problems
Dentsply Implants Manufacturing GmbH · XiVE® S plus Implant D3.0/L13 · Class 2 · Implant
All models of XiVE (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI EFRI322624232), received between Jun 20, 2023 and Apr 17, 2026 — classified as 14 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (10 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration10
- Off-Label Use6
- Failure to Osseointegrate3
- Fracture1
Patient problems
- Failure of Implant14
- Inflammation5
- Unspecified Infection4
- Osteolysis1
- Pocket Erosion1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2026Loss of Osseointegration
InjuryApr 17, 2026Loss of Osseointegration
CUSTOMER REPORTED AN IMPLANT LOSS - PERIIMPLANTITIS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 24915934 ↗InjuryApr 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED OCCLUSAL OVERLOAD AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24825051 ↗InjuryJan 13, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED MOBILITY ISSUES AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24051750 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED IMPLANT MOBILITY ISSUES AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23009455 ↗InjuryAug 15, 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
MAUDE report 22816164 ↗InjuryAug 15, 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
MAUDE report 22816146 ↗InjuryAug 13, 2025Off-Label Use; Failure to Osseointegrate; Off-Label Use; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22790878 ↗InjuryJun 1, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22121049 ↗InjuryMar 13, 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; Inflammation; Pocket Erosion; Unspecified Infection
MAUDE report 21592201 ↗InjuryAug 1, 2023Off-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
MAUDE report 17437922 ↗InjuryAug 1, 2023Off-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
MAUDE report 17437913 ↗InjuryJul 6, 2023Loss 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 17270938 ↗InjuryJun 20, 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 17163298 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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