Brånemark System® 28928 (UDI 07332747159615)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III TiU WP 5.0x11.5mm · 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 has 122 adverse event reports, with no deaths and 122 injuries. Most reports describe the implant losing its bond with bone, with some mentioning infection or abscess around the implant. 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
- 120
- Deaths reported
- 0
- Injuries reported
- 120
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 07332747159615), received between Dec 1, 2021 and Aug 12, 2026 — classified as 120 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (78 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 Osseointegration78
- Failure to Osseointegrate36
- Adverse Event Without Identified Device or Use Problem2
- Fracture2
- Insufficient Device Problem Information2
Patient problems
- Failure of Implant58
- Unspecified Infection30
- No Clinical Signs, Symptoms or Conditions20
- Abscess8
- Inflammation8
- Pain4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229026 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229019 ↗InjuryAug 4, 2026Loss of Osseointegration
InjuryAug 4, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
InjuryJun 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25671995 ↗InjuryJun 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25671989 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601410 ↗InjuryJun 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25601400 ↗InjuryJun 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 25540248 ↗InjuryJun 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 25540236 ↗InjuryJun 9, 2026Loss of Osseointegration
InjuryJun 9, 2026Loss of Osseointegration
InjuryMay 15, 2026Loss of Osseointegration
InjuryMay 15, 2026Loss of Osseointegration
InjuryApr 16, 2026Failure to Osseointegrate
InjuryApr 16, 2026Failure to Osseointegrate
InjuryMar 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24722268 ↗InjuryMar 30, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24721060 ↗InjuryFeb 18, 2026Loss of Osseointegration
InjuryFeb 18, 2026Loss of Osseointegration
InjuryJan 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24205050 ↗InjuryJan 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24205049 ↗InjuryJan 28, 2026Failure to Osseointegrate
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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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