NobelZygoma™ 38291 (UDI 07332747161625)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 45° 50mm · Class 2 · Implant
All models of NobelZygoma (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelZygoma implant has 145 FDA adverse event reports, with no deaths and 142 injuries. Most describe the implant failing to fuse with the bone or losing that bond, and patients were most often reported with implant failure. Some mention infection, pain or numbness. 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
- 147
- Deaths reported
- 0
- Injuries reported
- 144
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 07332747161625), received between Nov 8, 2021 and Sep 14, 2026 — classified as 144 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (84 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 Osseointegrate84
- Loss of Osseointegration31
- Osseointegration Problem12
- Fracture4
- Migration4
- Premature Separation4
- Adverse Event Without Identified Device or Use Problem2
- Device Markings/Labelling Problem2
Patient problems
- Failure of Implant106
- No Clinical Signs, Symptoms or Conditions30
- Unspecified Infection20
- Pain14
- Abscess2
- Bone Fracture(s)2
- Foreign Body In Patient2
- Numbness2
Recent adverse event reports
The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Failure to Osseointegrate
InjurySep 14, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25496533 ↗InjuryJun 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25496529 ↗InjuryJun 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25367618 ↗InjuryApr 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24974152 ↗InjuryApr 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24973339 ↗InjuryApr 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24786440 ↗InjuryApr 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24786437 ↗InjuryMar 21, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24657745 ↗InjuryMar 21, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24657744 ↗InjuryFeb 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24358421 ↗InjuryFeb 16, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24358419 ↗InjuryFeb 16, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24355511 ↗InjuryFeb 16, 2026Migration
DEVICE MOVED FROM INTENDED LOCATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24355509 ↗InjuryJan 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24106386 ↗InjuryJan 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24106381 ↗InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675185 ↗InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23675180 ↗InjuryOct 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23409676 ↗InjuryOct 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23409670 ↗InjurySep 17, 2025Osseointegration Problem; Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23080015 ↗InjurySep 17, 2025Osseointegration Problem; Osseointegration Problem
PRIMARY STABILITY COULDN¿T BE ACHIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23080011 ↗
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