XiVE® 32262452 (REF 26-2452)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · XiVE® S plus Implant D4.5/L11 · Class 2 · Implant
All models of XiVE (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI EFRI322624522), received between Jul 27, 2016 and Apr 17, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 Osseointegration2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Failure of Implant2
- Hypersensitivity/Allergic reaction1
- Osteolysis1
- Pocket Erosion1
- Reaction1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Osteolysis; Pocket Erosion; Unspecified Infection
MAUDE report 21853771 ↗InjuryJul 27, 2016Loss of Osseointegration; Appropriate Device Problem Term/Code Not Available; Loss of Osseointegration
IT WAS REPORTED THAT A XIVE S PLUS IMPLANT WAS INSERTED IN THE JAW OF A PATIENT ON (B)(6) 2013. THE IMPLANT WAS EXPOSED AND THE PATIENT STATED THAT THEY HAD ALLERGIC REACTIONS AND AN "ELECTRIC SENSATION" AFTER ONE AND A HALF YEARS. THE IMPLANT WAS REMOVED ON (B)(6) 2015.
Patient problems: Failure of Implant; Hypersensitivity/Allergic reaction; Reaction
MAUDE report 5826528 ↗
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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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