Brånemark System® 32120Recalls & reported problems
Nobel Biocare AB · Brånemark System® Mk III Groovy 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 Brånemark System implant is a bone implant made by Nobel Biocare and placed into bone. Its 463 reports mostly describe the implant losing its hold as the bone fails to bond with it, with some reports of infection, pain and fractures. The reports include no deaths and 462 injuries. 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
- 465
- Deaths reported
- 0
- Injuries reported
- 464
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 465 adverse event reports that list this exact device (DI 07332747000917), received between Sep 11, 2019 and Sep 14, 2026 — classified as 464 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (391 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 Osseointegration391
- Osseointegration Problem44
- Failure to Osseointegrate12
- Fracture10
- Adverse Event Without Identified Device or Use Problem4
- Premature Separation4
Patient problems
- Failure of Implant364
- Unspecified Infection80
- Pain66
- No Clinical Signs, Symptoms or Conditions40
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available35
- Numbness12
- Abscess4
- Sinus Perforation2
Recent adverse event reports
The 25 most recent of 465 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50749153 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50749149 ↗InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25739479 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25739476 ↗InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 25496558 ↗InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 25496557 ↗InjuryJun 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25493507 ↗InjuryJun 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25493505 ↗InjuryJun 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25493045 ↗InjuryJun 12, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25493037 ↗InjuryMay 28, 2026Loss of Osseointegration
InjuryMay 28, 2026Loss of Osseointegration
InjuryMay 12, 2026Loss of Osseointegration
InjuryMay 12, 2026Loss of Osseointegration
InjuryApr 30, 2026Loss of Osseointegration
InjuryApr 30, 2026Loss of Osseointegration
InjuryApr 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 24947409 ↗InjuryApr 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 24947397 ↗InjuryMar 12, 2026Loss of Osseointegration
InjuryMar 12, 2026Loss of Osseointegration
InjuryFeb 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24447938 ↗InjuryFeb 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24447935 ↗InjuryFeb 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24435203 ↗
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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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