Brånemark System® 28935Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk IV TiU RP 4.0x11.5mm · Class 2 · Implant
Quick summary
This Nobel Biocare Brånemark System implant is placed in bone. Most of the 303 reports describe the implant losing its bond with the bone, and some mention the device moving from its intended position, pain, or infection. The reports include 298 injuries and no deaths, and 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
- 303
- Deaths reported
- 0
- Injuries reported
- 298
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 303 adverse event reports that list this exact device (DI 07332747013238), received between Sep 11, 2019 and Jul 1, 2026 — classified as 298 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (235 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 Osseointegration235
- Failure to Osseointegrate42
- Adverse Event Without Identified Device or Use Problem8
- Osseointegration Problem8
- Material Deformation6
- Migration4
Patient problems
- Failure of Implant268
- Pain64
- Unspecified Infection62
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available15
- No Clinical Signs, Symptoms or Conditions14
- Numbness10
- Fistula4
- Implant Pain4
Recent adverse event reports
The 25 most recent of 303 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2026Loss of Osseointegration
InjuryJul 1, 2026Loss of Osseointegration
InjuryJun 26, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25643773 ↗InjuryJun 10, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25463946 ↗InjuryJun 10, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25463914 ↗InjuryMay 21, 2026Loss of Osseointegration
InjuryMay 21, 2026Loss of Osseointegration
InjuryApr 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24822855 ↗InjuryApr 8, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24822852 ↗InjuryMar 21, 2026Loss of Osseointegration
InjuryMar 21, 2026Loss of Osseointegration
InjuryMar 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24592220 ↗InjuryMar 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24585820 ↗InjuryMar 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24585817 ↗InjuryMar 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24585813 ↗InjuryMar 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 24541260 ↗InjuryMar 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 24541019 ↗InjuryMar 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 24540136 ↗InjuryMar 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 24540135 ↗InjuryDec 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23722847 ↗InjuryDec 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23722739 ↗InjuryNov 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23564715 ↗InjuryNov 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23564714 ↗InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 23562691 ↗InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 23562671 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.