Brånemark System® 34738 (UDI 07332747013504)Recalls & reported problems
Nobel Biocare AB · Brånemark System® Zygoma TiU 47.5mm · 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 dental implant is a root-form endosseous implant used in the upper jaw. The 34 reports describe implants that fail to bond with the surrounding bone or lose that bond after placement, along with pain, infection, sinus perforation, and a small number of fractures or misplacement; all 34 involve injuries and no deaths are reported. No recalls name this device, and no reports were filed in the past 12 months.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 07332747013504), received between Sep 12, 2019 and Dec 10, 2024 — classified as 34 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (20 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 Osseointegration20
- Failure to Osseointegrate10
- Malposition of Device4
- Fracture2
- Osseointegration Problem2
Patient problems
- Failure of Implant34
- Pain5
- Sinus Perforation4
- Unspecified Infection3
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 9, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 9, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 9, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 6, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18277916 ↗InjuryDec 6, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 18277740 ↗InjuryOct 10, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION
Patient problems: Failure of Implant
MAUDE report 17907921 ↗InjuryOct 10, 2023Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION
Patient problems: Failure of Implant
MAUDE report 17907696 ↗InjuryJun 27, 2023Fracture; Malposition of Device; Fracture; Malposition of Device
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY/SINUS PERFORATION.
Patient problems: Failure of Implant; Sinus Perforation
MAUDE report 17211587 ↗InjuryJun 27, 2023Fracture; Malposition of Device; Fracture; Malposition of Device
IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY/SINUS PERFORATION.
Patient problems: Failure of Implant; Sinus Perforation
MAUDE report 17211556 ↗InjuryMar 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16614706 ↗InjuryMar 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16614192 ↗InjuryMar 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16575712 ↗InjuryMar 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 16575667 ↗InjuryNov 7, 2022Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 15748147 ↗InjuryNov 7, 2022Osseointegration Problem; Osseointegration Problem
IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM.
Patient problems: Failure of Implant
MAUDE report 15746483 ↗InjuryJul 20, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15069096 ↗InjuryJul 20, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 15069088 ↗InjuryJul 12, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 14991179 ↗InjuryJul 12, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 14990963 ↗InjuryMay 4, 2022Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Sinus Perforation
MAUDE report 14281021 ↗InjuryMay 4, 2022Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Sinus Perforation
MAUDE report 14280970 ↗InjuryFeb 22, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13580235 ↗InjuryFeb 22, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 13580221 ↗InjuryNov 29, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 12886602 ↗
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- 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.
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