Brånemark System® 28913 (UDI 07332747001174)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III TiU RP 3.75x10mm · 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 screw-shaped device placed into bone. The 988 reports mostly describe the implant losing its bond with the bone, with pain, infection or numbness also reported. There are 988 injury reports and no deaths. Reports fell from 26 in the prior 12 months to 16 in the last 12. 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
- 988
- Deaths reported
- 0
- Injuries reported
- 988
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 988 adverse event reports that list this exact device (DI 07332747001174), received between Sep 10, 2019 and Jul 27, 2026 — classified as 988 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (712 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 Osseointegration712
- Failure to Osseointegrate169
- Osseointegration Problem56
- Fracture33
- Adverse Event Without Identified Device or Use Problem6
- Insufficient Device Problem Information6
- Material Deformation4
- Break2
Patient problems
- Failure of Implant948
- Pain261
- Unspecified Infection133
- Numbness65
- No Clinical Signs, Symptoms or Conditions14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Insufficient Information6
- Abscess4
Recent adverse event reports
The 25 most recent of 988 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50001330 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50001329 ↗InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25863862 ↗InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25863841 ↗InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25863833 ↗InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25863815 ↗InjuryJun 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25553519 ↗InjuryJun 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25553516 ↗InjuryApr 29, 2026Loss of Osseointegration
InjuryApr 29, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
InjuryFeb 16, 2026Loss of Osseointegration
InjuryJan 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24205330 ↗InjuryJan 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24205317 ↗InjuryJan 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24205316 ↗InjuryJan 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24205312 ↗InjuryOct 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23409805 ↗InjuryOct 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23409804 ↗InjuryOct 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23329347 ↗InjuryOct 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23329343 ↗InjuryOct 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23329307 ↗InjuryOct 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23329305 ↗InjurySep 12, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23044783 ↗InjurySep 12, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23044782 ↗InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22604741 ↗
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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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