Brånemark System® 32125Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III Shorty RP Ø4 · 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 dental implant is a screw placed in the jawbone to anchor a replacement tooth. All 128 reports are injuries, with no deaths; most describe the implant losing its bond with the bone, and some mention pain, numbness or infection. Reports fell to 6 in the last 12 months from 18 in the 12 months before. 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
- 128
- Deaths reported
- 0
- Injuries reported
- 128
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 07332747000962), received between Nov 9, 2021 and Jun 12, 2026 — classified as 128 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (116 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 Osseointegration116
- Failure to Osseointegrate8
- Adverse Event Without Identified Device or Use Problem2
- Migration2
Patient problems
- Failure of Implant110
- Pain22
- Unspecified Infection14
- No Clinical Signs, Symptoms or Conditions8
- Numbness8
- Abscess6
- Foreign Body In Patient2
- Implant Pain2
Recent adverse event reports
The 25 most recent of 128 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25493019 ↗InjuryJun 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25493017 ↗InjuryMay 21, 2026Loss of Osseointegration
InjuryMay 21, 2026Loss of Osseointegration
InjuryDec 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23773500 ↗InjuryDec 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23773499 ↗InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23078986 ↗InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23078978 ↗InjurySep 16, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 16, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22444282 ↗InjuryJul 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22444272 ↗InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 22, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 22, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21380652 ↗InjuryFeb 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21380651 ↗InjuryFeb 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21350375 ↗InjuryFeb 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 21350368 ↗InjuryFeb 5, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 5, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 7, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 20388598 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page