XiVERecalls & reported problems across all models
Dentsply Implants Manufacturing GmbH · 62 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12,456
- Deaths reported
- 0
- Injuries reported
- 12,455
- Recalls
- 0
We found 62 models of XiVE by Dentsply Implants Manufacturing GmbH in the FDA's device registry (GUDID). Together they are named in 12,456 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2016 and Sep 30, 2026 — classified as 12,455 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (6,676 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported XiVE problems
Device problems
- Failure to Osseointegrate6,676
- Loss of Osseointegration5,019
- Fracture763
- Off-Label Use55
- Malposition of Device12
- Damaged Thread6
- Migration or Expulsion of Device4
- Crack3
Patient problems
- Failure of Implant12,377
- Unspecified Infection3,468
- Inflammation2,149
- Osteolysis1,077
- Pocket Erosion750
- Implant Pain47
- Inadequate Osseointegration38
- No Clinical Signs, Symptoms or Conditions37
XiVE models
62 models, most reported first. Each model has its own page with its reports, recalls and device details.
- XiVE® 32262442IMPLANT, ENDOSSEOUS, ROOT-FORM2,022 reports
- XiVE® 32262441IMPLANT, ENDOSSEOUS, ROOT-FORM1,542 reports
- XiVE® 32262451IMPLANT, ENDOSSEOUS, ROOT-FORM1,245 reports
- XiVE® 32262452IMPLANT, ENDOSSEOUS, ROOT-FORM950 reports
- XiVE® 32262450IMPLANT, ENDOSSEOUS, ROOT-FORM919 reports
- XiVE® 32262440IMPLANT, ENDOSSEOUS, ROOT-FORM906 reports
- XiVE® 32262432IMPLANT, ENDOSSEOUS, ROOT-FORM905 reports
- XiVE® 32262443IMPLANT, ENDOSSEOUS, ROOT-FORM817 reports
- XiVE® 32262431IMPLANT, ENDOSSEOUS, ROOT-FORM778 reports
- XiVE® 32262433IMPLANT, ENDOSSEOUS, ROOT-FORM477 reports
- XiVE® 32262453IMPLANT, ENDOSSEOUS, ROOT-FORM319 reports
- XiVE® 32262460IMPLANT, ENDOSSEOUS, ROOT-FORM177 reports
- XiVE® 32262461IMPLANT, ENDOSSEOUS, ROOT-FORM170 reports
- XiVE® 32262445IMPLANT, ENDOSSEOUS, ROOT-FORM149 reports
- XiVE® 32262412IMPLANT, ENDOSSEOUS, ROOT-FORM138 reports
- XiVE® 32262462IMPLANT, ENDOSSEOUS, ROOT-FORM134 reports
- XiVE® 32262435IMPLANT, ENDOSSEOUS, ROOT-FORM110 reports
- XiVE® 32252441IMPLANT, ENDOSSEOUS, ROOT-FORM71 reports
- XiVE® 32262413IMPLANT, ENDOSSEOUS, ROOT-FORM67 reports
- XiVE® 32262455IMPLANT, ENDOSSEOUS, ROOT-FORM54 reports
- XiVE® 32252442IMPLANT, ENDOSSEOUS, ROOT-FORM54 reports
- XiVE® 32252432IMPLANT, ENDOSSEOUS, ROOT-FORM50 reports
- XiVE® 32262463IMPLANT, ENDOSSEOUS, ROOT-FORM44 reports
- XiVE® 32252450IMPLANT, ENDOSSEOUS, ROOT-FORM42 reports
- XiVE® 32252451IMPLANT, ENDOSSEOUS, ROOT-FORM35 reports
- XiVE® 32252431IMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- XiVE® 32252440IMPLANT, ENDOSSEOUS, ROOT-FORM26 reports
- XiVE® 32252443IMPLANT, ENDOSSEOUS, ROOT-FORM26 reports
- XiVE® 32262415IMPLANT, ENDOSSEOUS, ROOT-FORM23 reports
- XiVE® 32262465IMPLANT, ENDOSSEOUS, ROOT-FORM22 reports
- XiVE® 32252452IMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- XiVE® 32262422IMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- XiVE® 32252433IMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- XiVE® 32262423IMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- XiVE® 32262448IMPLANT, ENDOSSEOUS, ROOT-FORM13 reports
- XiVE® 32252435IMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- XiVE® 32252453IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- XiVE® 32262438IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- XiVE® 32252455IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- XiVE® 32262442IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- XiVE® 32262432IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- XiVE® 32262443IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- XiVE® 32252445IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- XiVE® 32261842IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- XiVE® 32262425IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- XiVE® 32262440IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- XiVE® 32262441IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- XiVE® 32262450IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- XiVE® 32262451IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- XiVE® 32262452IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- XiVE® 32262458IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- XiVE® 32261852IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- XiVE® 32261853IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- XiVE® 32261943IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- XiVE® 32252432IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- XiVE® 32262412IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- XiVE® 32262433IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- XiVE® 32262435IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- XiVE® 32262445IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- XiVE® 32262453IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- XiVE® 32262460IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- XiVE® 32262462IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent XiVE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50954951 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50954946 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50954841 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Osteolysis
MAUDE report 50952847 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Inflammation; Osteolysis
MAUDE report 50952781 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952651 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Osteolysis
MAUDE report 50952568 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50952412 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50952202 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Inflammation; Osteolysis
MAUDE report 50952100 ↗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 50947441 ↗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 30, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss with periimplantitis and osteolysis.
Patient problems: Inadequate Osseointegration; Inflammation; Osteolysis
MAUDE report 50945575 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50938631 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 50926486 ↗
Other Dentsply Implants Manufacturing GmbH products
- ASTRA TECH Implant System EV177 models · 37,200 reports
- ASTRA TECH Implant System166 models · 27,749 reports
- ANKYLOS112 models · 20,917 reports
- DS PrimeTaper61 models · 6,897 reports
- DS OmniTaper32 models · 2,128 reports
- DS Implants44 models · 145 reports
- FRIADENT23 models · 55 reports
- FRIALIT12 models · 35 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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