NobelZygoma™ 38282 (UDI 07332747161533)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 0° 50mm · Class 2 · Implant
All models of NobelZygoma (36)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07332747161533), received between Mar 8, 2022 and Sep 10, 2026 — classified as 11 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
- Loss of Osseointegration4
- Activation, Positioning or Separation Problem2
- Failure to Osseointegrate2
- Patient Device Interaction Problem2
Patient problems
- Failure of Implant8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection2
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724396 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724393 ↗InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionOct 11, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IMPLANT MALFUNCTIONED DUE TO PART/INTERFACE DOES NOT FIT/ALIGN.
Patient problems: Failure of Implant
MAUDE report 17915090 ↗InjuryOct 11, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IMPLANT MALFUNCTIONED DUE TO PART/INTERFACE DOES NOT FIT/ALIGN.
Patient problems: Failure of Implant
MAUDE report 17915088 ↗InjurySep 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED BECAUSE PRIMARY STABILITY COULD NOT BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17693277 ↗InjurySep 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IMPLANT FAILED BECAUSE PRIMARY STABILITY COULD NOT BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17693274 ↗MalfunctionJun 5, 2023Fracture; Fracture
THE IMPLANT MALFUNCTIONED DUE TO IT FRACTURING DURING PLACEMENT. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 17064632 ↗InjuryJun 5, 2023Fracture; Fracture
THE IMPLANT MALFUNCTIONED DUE TO IT FRACTURING DURING PLACEMENT. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 17063845 ↗InjuryJul 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14949945 ↗InjuryJul 7, 2022Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14949883 ↗MalfunctionMar 8, 2022Fracture; Fracture
THE IMPLANT MALFUNCTIONED DUE TO IT FRACTURING DURING PLACEMENT. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 13695725 ↗InjuryMar 8, 2022Fracture; Fracture
THE IMPLANT MALFUNCTIONED DUE TO IT FRACTURING DURING PLACEMENT. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Patient problems: Failure of Implant
MAUDE report 13695661 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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