NobelZygoma™ 38277 (UDI 07332747098778)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 0° 37.5mm · Class 2 · Implant
All models of NobelZygoma (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07332747098778), received between Jan 21, 2020 and Jul 28, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration6
- Failure to Osseointegrate3
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Failure of Implant3
- Insufficient Information2
- Unspecified Infection2
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50062052 ↗InjuryJul 28, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50062051 ↗InjuryJun 11, 2026Loss of Osseointegration
InjuryJun 11, 2026Loss of Osseointegration
InjuryJul 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22651169 ↗InjuryJul 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22651147 ↗InjuryMay 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER INDICATED THE IMPLANT FAILED, HOWEVER BASED ON THE AVAILABLE INFORMATION THE EXACT ISSUE COULD NOT BE IDENTIFIED.
Patient problems: Insufficient Information
MAUDE report 14457339 ↗InjuryMay 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER INDICATED THE IMPLANT FAILED, HOWEVER BASED ON THE AVAILABLE INFORMATION THE EXACT ISSUE COULD NOT BE IDENTIFIED.
Patient problems: Insufficient Information
MAUDE report 14456972 ↗InjuryApr 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14047011 ↗InjuryApr 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14046975 ↗InjuryJan 21, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED BECAUSE PRIMARY STABILITY COULD NOT BE ACHIEVED.
Patient problems: Failure of Implant
MAUDE report 9609915 ↗
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 18, 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