Brånemark System® 28934Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk IV TiU RP 4.0x10mm · Class 2 · Implant
Quick summary
This Brånemark System dental implant has 373 reports, all of them injury reports, and no deaths. Most describe the implant losing its bond with the jawbone, and others report pain, infection or numbness. No recalls name this device.
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
- 375
- Deaths reported
- 0
- Injuries reported
- 375
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 375 adverse event reports that list this exact device (DI 07332747013221), received between Sep 11, 2019 and Sep 16, 2026 — classified as 375 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (311 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration311
- Failure to Osseointegrate36
- Osseointegration Problem10
- Adverse Event Without Identified Device or Use Problem8
- Fracture4
- Migration4
- Insufficient Device Problem Information2
Patient problems
- Failure of Implant296
- Pain71
- Unspecified Infection61
- No Clinical Signs, Symptoms or Conditions40
- Numbness16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available13
- Abscess8
- Bone Fracture(s)4
Recent adverse event reports
The 25 most recent of 375 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50795786 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50795785 ↗InjuryAug 25, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440386 ↗InjuryAug 25, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440385 ↗InjuryJul 29, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50076997 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50027400 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026816 ↗InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25818878 ↗InjuryJul 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25818857 ↗InjuryJul 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25698848 ↗InjuryJul 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25698847 ↗InjuryJun 13, 2026Loss of Osseointegration
InjuryJun 13, 2026Loss of Osseointegration
InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25495967 ↗InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25495963 ↗InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25495960 ↗InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25495958 ↗InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25495945 ↗InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25495943 ↗InjuryJun 10, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25463924 ↗InjuryJun 10, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25463908 ↗InjuryJun 6, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25420065 ↗InjuryJun 6, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25420061 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.