Brånemark SystemRecalls & reported problems across all models
Nobel Biocare AB · 141 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19,899
- Deaths reported
- 0
- Injuries reported
- 19,834
- Recalls
- 0
We found 141 models of Brånemark System by Nobel Biocare AB in the FDA's device registry (GUDID). Together they are named in 19,899 adverse event reports in the FDA's MAUDE database, received between Aug 17, 2017 and Sep 30, 2026 — classified as 19,834 injuries, 65 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (12,682 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 Brånemark System problems
Device problems
- Loss of Osseointegration12,682
- Failure to Osseointegrate5,248
- Osseointegration Problem1,036
- Fracture377
- Adverse Event Without Identified Device or Use Problem286
- Migration65
- Insufficient Device Problem Information48
- Patient Device Interaction Problem32
Patient problems
- Failure of Implant15,689
- Pain3,364
- Unspecified Infection3,313
- No Clinical Signs, Symptoms or Conditions2,052
- Numbness798
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available530
- Abscess337
- Implant Pain131
Brånemark System models
141 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Brånemark System® 28913IMPLANT, ENDOSSEOUS, ROOT-FORM1,289 reports
- Brånemark System® 28913IMPLANT, ENDOSSEOUS, ROOT-FORM988 reports
- Brånemark System® 28915IMPLANT, ENDOSSEOUS, ROOT-FORM860 reports
- Brånemark System® 28914IMPLANT, ENDOSSEOUS, ROOT-FORM825 reports
- Brånemark System® 28920IMPLANT, ENDOSSEOUS, ROOT-FORM746 reports
- Brånemark System® 28914IMPLANT, ENDOSSEOUS, ROOT-FORM699 reports
- Brånemark System® 28915IMPLANT, ENDOSSEOUS, ROOT-FORM640 reports
- Brånemark System® 32120IMPLANT, ENDOSSEOUS, ROOT-FORM465 reports
- Brånemark System® 28920IMPLANT, ENDOSSEOUS, ROOT-FORM448 reports
- Brånemark System® 32122IMPLANT, ENDOSSEOUS, ROOT-FORM396 reports
- Brånemark System® 28927IMPLANT, ENDOSSEOUS, ROOT-FORM378 reports
- Brånemark System® 28936IMPLANT, ENDOSSEOUS, ROOT-FORM376 reports
- Brånemark System® 28934IMPLANT, ENDOSSEOUS, ROOT-FORM375 reports
- Brånemark System® 28916IMPLANT, ENDOSSEOUS, ROOT-FORM374 reports
- Brånemark System® 28912IMPLANT, ENDOSSEOUS, ROOT-FORM373 reports
- Brånemark System® 28921IMPLANT, ENDOSSEOUS, ROOT-FORM364 reports
- Brånemark System® 28912IMPLANT, ENDOSSEOUS, ROOT-FORM362 reports
- Brånemark System® 32127IMPLANT, ENDOSSEOUS, ROOT-FORM360 reports
- Brånemark System® 32121IMPLANT, ENDOSSEOUS, ROOT-FORM358 reports
- Brånemark System® 28927IMPLANT, ENDOSSEOUS, ROOT-FORM352 reports
- Brånemark System® 28922IMPLANT, ENDOSSEOUS, ROOT-FORM324 reports
- Brånemark System® 28935IMPLANT, ENDOSSEOUS, ROOT-FORM303 reports
- Brånemark System® 28919IMPLANT, ENDOSSEOUS, ROOT-FORM296 reports
- Brånemark System® 28921IMPLANT, ENDOSSEOUS, ROOT-FORM271 reports
- Brånemark System® 32128IMPLANT, ENDOSSEOUS, ROOT-FORM259 reports
- Brånemark System® 28922IMPLANT, ENDOSSEOUS, ROOT-FORM256 reports
- Brånemark System® 28919IMPLANT, ENDOSSEOUS, ROOT-FORM252 reports
- Brånemark System® 32134IMPLANT, ENDOSSEOUS, ROOT-FORM251 reports
- Brånemark System® 28906IMPLANT, ENDOSSEOUS, ROOT-FORM246 reports
- Brånemark System® 28916IMPLANT, ENDOSSEOUS, ROOT-FORM240 reports
- Brånemark System® 32129IMPLANT, ENDOSSEOUS, ROOT-FORM226 reports
- Brånemark System® 32126IMPLANT, ENDOSSEOUS, ROOT-FORM198 reports
- Brånemark System® 28937IMPLANT, ENDOSSEOUS, ROOT-FORM196 reports
- Brånemark System® 28911IMPLANT, ENDOSSEOUS, ROOT-FORM193 reports
- Brånemark System® 32119IMPLANT, ENDOSSEOUS, ROOT-FORM183 reports
- Brånemark System® 28941IMPLANT, ENDOSSEOUS, ROOT-FORM180 reports
- Brånemark System® 28928IMPLANT, ENDOSSEOUS, ROOT-FORM176 reports
- Brånemark System® 28926IMPLANT, ENDOSSEOUS, ROOT-FORM172 reports
- Brånemark System® 28933IMPLANT, ENDOSSEOUS, ROOT-FORM165 reports
- Brånemark System® 32114IMPLANT, ENDOSSEOUS, ROOT-FORM160 reports
- Brånemark System® 28907IMPLANT, ENDOSSEOUS, ROOT-FORM158 reports
- Brånemark System® 28918IMPLANT, ENDOSSEOUS, ROOT-FORM158 reports
- Brånemark System® 28926IMPLANT, ENDOSSEOUS, ROOT-FORM158 reports
- Brånemark System® 32133IMPLANT, ENDOSSEOUS, ROOT-FORM156 reports
- Brånemark System® 28911IMPLANT, ENDOSSEOUS, ROOT-FORM153 reports
- Brånemark System® 32118IMPLANT, ENDOSSEOUS, ROOT-FORM146 reports
- Brånemark System® 32125IMPLANT, ENDOSSEOUS, ROOT-FORM128 reports
- Brånemark System® 32123IMPLANT, ENDOSSEOUS, ROOT-FORM122 reports
- Brånemark System® 28906IMPLANT, ENDOSSEOUS, ROOT-FORM120 reports
- Brånemark System® 28928IMPLANT, ENDOSSEOUS, ROOT-FORM120 reports
- Brånemark System® 28907IMPLANT, ENDOSSEOUS, ROOT-FORM110 reports
- Brånemark System® 28923IMPLANT, ENDOSSEOUS, ROOT-FORM104 reports
- Brånemark System® 28908IMPLANT, ENDOSSEOUS, ROOT-FORM97 reports
- Brånemark System® 28908IMPLANT, ENDOSSEOUS, ROOT-FORM92 reports
- Brånemark System® 28942IMPLANT, ENDOSSEOUS, ROOT-FORM91 reports
- Brånemark System® 28940IMPLANT, ENDOSSEOUS, ROOT-FORM90 reports
- Brånemark System® 32130IMPLANT, ENDOSSEOUS, ROOT-FORM88 reports
- Brånemark System® 32135IMPLANT, ENDOSSEOUS, ROOT-FORM88 reports
- Brånemark System® 34735IMPLANT, ENDOSSEOUS, ROOT-FORM87 reports
- Brånemark System® 32132IMPLANT, ENDOSSEOUS, ROOT-FORM86 reports
- Brånemark System® 28918IMPLANT, ENDOSSEOUS, ROOT-FORM84 reports
- Brånemark System® 28929IMPLANT, ENDOSSEOUS, ROOT-FORM82 reports
- Brånemark System® 32115IMPLANT, ENDOSSEOUS, ROOT-FORM80 reports
- Brånemark System® 28923IMPLANT, ENDOSSEOUS, ROOT-FORM77 reports
- Brånemark System® 28932IMPLANT, ENDOSSEOUS, ROOT-FORM69 reports
- Brånemark System® 28925IMPLANT, ENDOSSEOUS, ROOT-FORM66 reports
- Brånemark System® 34724IMPLANT, ENDOSSEOUS, ROOT-FORM65 reports
- Brånemark System® 32116IMPLANT, ENDOSSEOUS, ROOT-FORM64 reports
- Brånemark System® 34737IMPLANT, ENDOSSEOUS, ROOT-FORM63 reports
- Brånemark System® 28925IMPLANT, ENDOSSEOUS, ROOT-FORM61 reports
- Brånemark System® 28885IMPLANT, ENDOSSEOUS, ROOT-FORM60 reports
- Brånemark System® 34735IMPLANT, ENDOSSEOUS, ROOT-FORM54 reports
- Brånemark System® 28929IMPLANT, ENDOSSEOUS, ROOT-FORM52 reports
- Brånemark System® 32117IMPLANT, ENDOSSEOUS, ROOT-FORM48 reports
- Brånemark System® 28917IMPLANT, ENDOSSEOUS, ROOT-FORM48 reports
- Brånemark System® 28939IMPLANT, ENDOSSEOUS, ROOT-FORM42 reports
- Brånemark System® 34723IMPLANT, ENDOSSEOUS, ROOT-FORM42 reports
- Brånemark System® 28909IMPLANT, ENDOSSEOUS, ROOT-FORM39 reports
- Brånemark System® 34739IMPLANT, ENDOSSEOUS, ROOT-FORM38 reports
- Brånemark System® 34738IMPLANT, ENDOSSEOUS, ROOT-FORM34 reports
- Brånemark System® 28885IMPLANT, ENDOSSEOUS, ROOT-FORM34 reports
- Brånemark System® 34724IMPLANT, ENDOSSEOUS, ROOT-FORM33 reports
- Brånemark System® 32136IMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- Brånemark System® 34736IMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- Brånemark System® 34737IMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- Brånemark System® 34739IMPLANT, ENDOSSEOUS, ROOT-FORM29 reports
- Brånemark System® 28909IMPLANT, ENDOSSEOUS, ROOT-FORM29 reports
- Brånemark System® 34736IMPLANT, ENDOSSEOUS, ROOT-FORM28 reports
- Brånemark System® 32137IMPLANT, ENDOSSEOUS, ROOT-FORM26 reports
- Brånemark System® 28887IMPLANT, ENDOSSEOUS, ROOT-FORM26 reports
- Brånemark System® 34740IMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- Brånemark System® 28886IMPLANT, ENDOSSEOUS, ROOT-FORM22 reports
- Brånemark System® 28892IMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- Brånemark System® 28938IMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- Brånemark System® 28862IMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- Brånemark System® 28887IMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- Brånemark System® 28930IMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- Brånemark System® 28943IMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- Brånemark System® 28865IMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- Brånemark System® 28895IMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
Recent Brånemark System 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: Unspecified Infection
MAUDE report 50953720 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50953719 ↗InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953591 ↗InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953589 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953581 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953576 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953318 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953314 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953303 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953301 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953300 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953299 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953297 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953294 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953281 ↗
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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