XiVE® 32262453 (REF 26-2453)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · XiVE® S plus Implant D4.5/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 S plus dental implant is a root-form implant placed in the jawbone. All 319 reports are injuries, mostly describing implants that failed to bond with the bone or later lost that bond, and many mention infection and bone loss around the implant. No deaths are reported. No recalls name this device. Reports fell to 35 in the last 12 months from 80 in the previous 12.
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
- 319
- Deaths reported
- 0
- Injuries reported
- 319
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 319 adverse event reports that list this exact device (DI 07392532208935), received between Jun 19, 2023 and Sep 18, 2026 — classified as 319 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (174 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 Osseointegrate174
- Loss of Osseointegration139
- Fracture5
- Damaged Thread1
Patient problems
- Failure of Implant317
- Unspecified Infection92
- Inflammation77
- Osteolysis35
- Pocket Erosion22
- Deformity/ Disfigurement1
- Discomfort1
- Inadequate Osseointegration1
Recent adverse event reports
The 25 most recent of 319 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831194 ↗InjurySep 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50738471 ↗InjuryAug 12, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50222770 ↗InjuryAug 5, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with peri-implantitis.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50142259 ↗InjuryAug 5, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection, inflammation and Osteolysis.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50139959 ↗InjuryJul 28, 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 50055687 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. The patient also reported that they had inflammation.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50008432 ↗InjuryJul 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25811212 ↗InjuryJun 30, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25668799 ↗InjuryJun 24, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25610413 ↗InjuryJun 24, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25608491 ↗InjuryJun 12, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25483252 ↗InjuryJun 9, 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 25443569 ↗InjuryJun 5, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25406676 ↗InjuryJun 5, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25406394 ↗InjuryJun 2, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, INFECTION, OSTEOLYSIS, PERIIMPLANTITIS.
Patient problems: Failure of Implant; Inflammation; Low Oxygen Saturation; Unspecified Infection
MAUDE report 25364437 ↗InjuryMay 29, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25330564 ↗InjuryMay 1, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25056073 ↗InjuryApr 23, 2026Damaged Thread
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT IMPLANT FRACTURE AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 24961931 ↗InjuryMar 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24624322 ↗InjuryMar 14, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24599869 ↗InjuryFeb 17, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 24364898 ↗InjuryFeb 9, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Osteolysis
MAUDE report 24300737 ↗InjuryFeb 8, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE ABUTMENT IMPLANT, PERIIMPLANTITIS, AN UNSPECIFIED INFECTION AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 24288693 ↗InjuryFeb 8, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE ABUTMENT IMPLANT, PERIIMPLANTITIS, AN UNSPECIFIED INFECTION AND A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation; Unspecified Infection
MAUDE report 24288686 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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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 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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