NobelZygoma™ 38287 (UDI 07332747102772)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 45° 40mm · Class 2 · Implant
All models of NobelZygoma (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This NobelZygoma dental implant is a root-form screw placed in the jaw to support a tooth replacement. The 29 reports mostly describe the implant not bonding with the surrounding bone as expected, or breaking, along with pain and infection in the area. All 29 reports involve injuries, with no deaths. There are no recalls naming 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
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07332747102772), received between Sep 11, 2019 and Jul 27, 2026 — classified as 29 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (14 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
- Failure to Osseointegrate14
- Loss of Osseointegration8
- Fracture6
- Insufficient Device Problem Information1
Patient problems
- Failure of Implant23
- Pain6
- Unspecified Infection6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 29 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 50014794 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50014792 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50014791 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50014789 ↗InjuryJan 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24123884 ↗InjuryJan 20, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24123866 ↗InjuryJan 17, 2025Fracture; Fracture
InjuryJan 17, 2025Fracture; Fracture
InjuryJan 2, 2025Fracture; Fracture
InjuryJan 2, 2025Fracture; Fracture
InjuryJan 2, 2025Fracture; Fracture
InjuryJan 2, 2025Fracture; Fracture
InjuryApr 27, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 14227431 ↗InjuryApr 27, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 14227280 ↗InjuryNov 3, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12748593 ↗InjuryNov 3, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 12748570 ↗InjuryMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
PRODUCT FAILED DUE TO AN INABILITY TO SEPARATE COMPONENTS.
Patient problems: Failure of Implant
MAUDE report 9816285 ↗InjuryJan 23, 2020Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9620484 ↗InjurySep 23, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9103047 ↗InjurySep 14, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9057343 ↗InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9051372 ↗InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9022695 ↗InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9022683 ↗InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 9019861 ↗InjurySep 12, 2019Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Pain; Unspecified Infection
MAUDE report 9005110 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- 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.
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