Multi-unit Abutment XealRecalls & reported problems across all models
Nobel Biocare AB · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 43
- Recalls
- 0
We found 13 models of Multi-unit Abutment Xeal by Nobel Biocare AB in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2021 and Oct 29, 2025 — classified as 43 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (14 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 Multi-unit Abutment Xeal problems
Device problems
- Failure to Osseointegrate14
- Loss of Osseointegration12
- Material Disintegration8
- Insufficient Device Problem Information4
- Fracture2
- Mechanical Problem2
- Patient Device Interaction Problem2
- Premature Separation2
Patient problems
- Failure of Implant38
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information4
- Pain4
Multi-unit Abutment Xeal models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Multi-unit Abutment Xeal™ 300184ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS8 reports
- Multi-unit Abutment Xeal™ 300171ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS6 reports
- Multi-unit Abutment Xeal™ 300172ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS4 reports
- Multi-unit Abutment Xeal™ 300174ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS4 reports
- Multi-unit Abutment Xeal™ 300182ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS4 reports
- Multi-unit Abutment Xeal™ 300185ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS4 reports
- Multi-unit Abutment Xeal™ 300172Abutment, implant, dental, endosseous4 reports
- Multi-unit Abutment Xeal™ 300178Abutment, implant, dental, endosseous4 reports
- Multi-unit Abutment Xeal™ 300176ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- Multi-unit Abutment Xeal™ 300188ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- Multi-unit Abutment Xeal™ 300190ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- Multi-unit Abutment Xeal™ 300184Abutment, implant, dental, endosseous2 reports
- Multi-unit Abutment Xeal™ 300190Abutment, implant, dental, endosseous2 reports
Recent Multi-unit Abutment Xeal adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23419381 ↗InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23419375 ↗InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23419197 ↗InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23419195 ↗InjuryFeb 13, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 13, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 13, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 13, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 4, 2025Material Disintegration; Material Disintegration
FOREIGN PARTICLES ON THE PRODUCT/IN PACK.
Patient problems: Failure of Implant
MAUDE report 21308902 ↗MalfunctionFeb 4, 2025Material Disintegration; Material Disintegration
FOREIGN PARTICLES ON THE PRODUCT/IN PACK.
Patient problems: Failure of Implant
MAUDE report 21308880 ↗InjuryJan 19, 2025Material Disintegration; Material Disintegration
FOREIGN PARTICLES ON THE PRODUCT/IN PACK.
Patient problems: Failure of Implant
MAUDE report 21188155 ↗MalfunctionJan 19, 2025Material Disintegration; Material Disintegration
FOREIGN PARTICLES ON THE PRODUCT/IN PACK.
Patient problems: Failure of Implant
MAUDE report 21188154 ↗MalfunctionJan 19, 2025Material Disintegration; Material Disintegration
FOREIGN PARTICLES ON THE PRODUCT/IN PACK.
Patient problems: Failure of Implant
MAUDE report 21188132 ↗InjuryJan 19, 2025Material Disintegration; Material Disintegration
FOREIGN PARTICLES ON THE PRODUCT/IN PACK.
Patient problems: Failure of Implant
MAUDE report 21188130 ↗MalfunctionJan 19, 2025Material Disintegration; Material Disintegration
FOREIGN PARTICLES ON THE PRODUCT/IN PACK.
Patient problems: Failure of Implant
MAUDE report 21188128 ↗
Other Nobel Biocare AB products
- NobelActive56 models · 152,066 reports
- NobelReplace120 models · 138,221 reports · 15 recalls
- NobelParallel54 models · 132,525 reports
- NobelActive TiUltra28 models · 82,969 reports
- NobelParallel Conical Connection TiUltra27 models · 68,868 reports
- Replace Select107 models · 33,616 reports
- NobelReplace Conical Connection TiUltra15 models · 31,165 reports
- NobelSpeedy88 models · 24,246 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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