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 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply XiVE dental implant is placed into bone to support a replacement tooth. The 942 reports mostly describe patients losing the implant after it failed to bond with the bone, and mention infections, inflammation and bone loss around the implant. The reports include no deaths and 941 injuries, and no recalls name this device. Reports fell to 119 over the last year from 317 in the year before.
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
- 950
- Deaths reported
- 0
- Injuries reported
- 949
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 950 adverse event reports that list this exact device (DI 07392532208928), received between Jun 16, 2023 and Sep 30, 2026 — classified as 949 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (523 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 Osseointegrate523
- Loss of Osseointegration420
- Fracture6
- Migration or Expulsion of Device2
- Malposition of Device1
- Material Deformation1
Patient problems
- Failure of Implant942
- Unspecified Infection280
- Inflammation173
- Osteolysis78
- Pocket Erosion41
- No Clinical Signs, Symptoms or Conditions5
- Deformity/ Disfigurement3
- Inadequate Osseointegration3
Recent adverse event reports
The 25 most recent of 950 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50954946 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Osteolysis
MAUDE report 50952847 ↗InjurySep 28, 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 50913982 ↗InjurySep 14, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50757321 ↗InjurySep 14, 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 50752519 ↗InjurySep 12, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746390 ↗InjurySep 12, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746388 ↗InjuryAug 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant; Inadequate Osseointegration; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50485656 ↗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 50476896 ↗InjuryAug 27, 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 50474805 ↗InjuryAug 21, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis.
Patient problems: Failure of Implant; Inflammation
MAUDE report 50370447 ↗InjuryAug 12, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50222712 ↗InjuryAug 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50210521 ↗InjuryAug 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50210479 ↗InjuryAug 11, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50210418 ↗InjuryAug 7, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50172550 ↗InjuryAug 4, 2026Failure to Osseointegrate
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 50130226 ↗InjuryAug 4, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50127489 ↗InjuryAug 4, 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 50127438 ↗InjuryAug 3, 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 50115413 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50047231 ↗InjuryJul 27, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Failure of Implant
MAUDE report 50006724 ↗InjuryJul 14, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25811567 ↗InjuryJul 10, 2026Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS - INFECTION, MASSIVE PERIIMPLANTITIS, OSTEOLYSIS, BONE RESORPTION.
Patient problems: Failure of Implant; Inflammation; Osteolysis; Unspecified Infection
MAUDE report 25779672 ↗InjuryJul 6, 2026Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 25719817 ↗
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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