XiVE® 32262443 (REF 26-2443)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · XiVE® S plus Implant D3.8/L13 · Class 2 · Implant
All models of XiVE (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply XiVE dental implant has 814 adverse event reports, all describing injuries, and no deaths. Most reports describe the implant failing to bond with the jawbone or losing that bond later, and some mention fractures, infection and inflammation around the implant. No recalls name this device. Reports fell from 233 in the previous 12 months to 83 in the most recent 12 months.
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
- 817
- Deaths reported
- 0
- Injuries reported
- 817
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 817 adverse event reports that list this exact device (DI 07392532208874), received between Jun 16, 2023 and Sep 30, 2026 — classified as 817 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (374 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 Osseointegrate374
- Loss of Osseointegration352
- Fracture88
- Damaged Thread3
- Crack1
- Malposition of Device1
Patient problems
- Failure of Implant812
- Unspecified Infection172
- Inflammation155
- Pocket Erosion68
- Osteolysis65
- Implant Pain6
- Inadequate Osseointegration5
- Infiltration into Tissue1
Recent adverse event reports
The 25 most recent of 817 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50952202 ↗InjurySep 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50945652 ↗InjurySep 17, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50807394 ↗InjurySep 17, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50807373 ↗InjurySep 17, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50807329 ↗InjuryAug 12, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50223389 ↗InjuryAug 12, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. The patient also reported to have had inflammation.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50222429 ↗InjuryAug 8, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection and Osteolysis.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 50185320 ↗InjuryAug 5, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with infection.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50141361 ↗InjuryAug 5, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50140880 ↗InjuryJul 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50067812 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50011379 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50010618 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50006234 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50006199 ↗InjuryJul 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50005931 ↗InjuryJul 10, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS; PERIIMPLANTITIS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25782656 ↗InjuryJul 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25680941 ↗InjuryJul 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25680929 ↗InjuryJun 25, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS; PERIIMPLANTITIS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25629670 ↗InjuryJun 24, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS / LOOSENING.
Patient problems: Failure of Implant
MAUDE report 25612338 ↗InjuryJun 23, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. THE PATIENT ALSO REPORTED TO HAVE HAD INFLAMMATION.
Patient problems: Failure of Implant; Inflammation
MAUDE report 25594759 ↗InjuryJun 23, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. ALSO, IT WAS REPORTED THAT THEY HAD OSTEOLYSIS.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 25593424 ↗InjuryJun 12, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25483285 ↗InjuryJun 8, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT BREAKAGE. THE DENTAL IMPLANT WAS EXPLANTED AS A RESULT.
Patient problems: Failure of Implant
MAUDE report 25428070 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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