Brånemark System® 28933Recalls & reported problems
Nobel Biocare AB · Brånemark System Mk IV TiU RP 4.0x8.5mm · Class 2 · Implant
All models of Brånemark System (141)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare Brånemark System implant is a root-form implant placed into bone. All 165 of its adverse event reports are injuries, with no deaths. Most describe the implant losing its bond with the bone or never bonding with it, and patients report implant failure, pain and infection. 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
- 165
- Deaths reported
- 0
- Injuries reported
- 165
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 07332747013283), received between Sep 11, 2019 and Jul 27, 2026 — classified as 165 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (130 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration130
- Failure to Osseointegrate19
- Osseointegration Problem8
- Adverse Event Without Identified Device or Use Problem2
- Device Markings/Labelling Problem2
- Fracture2
- Insufficient Device Problem Information2
Patient problems
- Failure of Implant127
- Pain33
- Unspecified Infection28
- No Clinical Signs, Symptoms or Conditions16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Abscess8
- Numbness6
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 165 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030373 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030371 ↗InjuryJul 2, 2026Loss of Osseointegration
InjuryJul 2, 2026Loss of Osseointegration
InjuryJun 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25526226 ↗InjuryJun 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25526223 ↗InjuryJun 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25526218 ↗InjuryJun 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25526208 ↗InjuryMay 5, 2026Loss of Osseointegration
InjuryMay 5, 2026Loss of Osseointegration
InjuryMay 5, 2026Loss of Osseointegration
InjuryMay 5, 2026Loss of Osseointegration
InjuryApr 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24989737 ↗InjuryApr 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24989624 ↗InjuryApr 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 24891205 ↗InjuryApr 15, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 24891199 ↗InjuryApr 12, 2026Loss of Osseointegration
InjuryApr 11, 2026Loss of Osseointegration
InjuryMar 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24502274 ↗InjuryMar 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24502273 ↗InjuryDec 16, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23823003 ↗InjuryDec 16, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23823001 ↗InjuryDec 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23699799 ↗InjuryDec 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23699798 ↗InjuryNov 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23446019 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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