XiVE® 32262432 (REF 26-2432)Recalls & reported problems
Dentsply Implants Manufacturing GmbH · XiVE® S plus Implant D3.4/L11 · 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 placed in the jawbone to hold a replacement tooth. Reports mostly describe implants lost after failing to fuse with the bone, sometimes with progressive bone loss, and some mention infection or inflammation. There are 906 reports, no deaths and 906 injuries. No recalls name this device. Reports fell from 245 in the prior 12 months to 112 in the latest 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
- 905
- Deaths reported
- 0
- Injuries reported
- 905
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 905 adverse event reports that list this exact device (DI 07392532208805), received between Jun 16, 2023 and Sep 18, 2026 — classified as 905 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (503 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 Osseointegrate503
- Loss of Osseointegration314
- Fracture89
- Off-Label Use2
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant901
- Unspecified Infection259
- Inflammation162
- Osteolysis73
- Pocket Erosion69
- Inadequate Osseointegration2
- No Clinical Signs, Symptoms or Conditions2
- Deformity/ Disfigurement1
Recent adverse event reports
The 25 most recent of 905 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50831144 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50831090 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775787 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774549 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 50479290 ↗InjuryAug 27, 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 50478462 ↗InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss with infection.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50476532 ↗InjuryAug 20, 2026Loss of Osseointegration
DIDHA178,20260815:Customer reported Implant loss
Patient problems: Failure of Implant; Inadequate Osseointegration; Inflammation; Unspecified Infection
MAUDE report 50351419 ↗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 50220786 ↗InjuryAug 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss due to bone loss.
Patient problems: Failure of Implant; Osteolysis
MAUDE report 50212711 ↗InjuryAug 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss due to infection.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50212666 ↗InjuryAug 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had inflammation.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50211173 ↗InjuryAug 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection and inflammation, Osteolysis.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50209444 ↗InjuryAug 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had unspecified infection.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 50208071 ↗InjuryAug 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss- infection - mobility - gradual bone loss loosened implant with bone loss and pus discharge.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 50203851 ↗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 50142214 ↗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 50141314 ↗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 50141256 ↗InjuryAug 5, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. Also, it was reported that they had inflammation.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50140317 ↗InjuryJul 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50068125 ↗InjuryJul 27, 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 50009235 ↗InjuryJul 15, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25828778 ↗InjuryJul 6, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS WITH INFECTION, GRADUAL BONE LOSS, AND PERIIMPLANTITIS.
Patient problems: Failure of Implant
MAUDE report 25718708 ↗InjuryJun 23, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25593462 ↗InjuryJun 23, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25593166 ↗
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- 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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