NobelZygoma™ 38285 (UDI 07332747161564)Recalls & reported problems
Nobel Biocare AB · NobelZygoma™ 45° 35mm · 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 is a root-form implant placed in the cheekbone. Of its 170 reports, 164 are filed as injuries, and most describe the implant failing to bond with the bone or losing that bond. The reports mention no deaths, and no recalls name this device. Reports fell over the past 12 months, with 10 compared with 30 in the year before.
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
- 170
- Deaths reported
- 0
- Injuries reported
- 164
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 07332747161564), received between Nov 1, 2021 and Aug 14, 2026 — classified as 164 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (102 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 Osseointegrate102
- Loss of Osseointegration38
- Fracture8
- Adverse Event Without Identified Device or Use Problem6
- Osseointegration Problem6
- Patient Device Interaction Problem6
- Activation, Positioning or Separation Problem2
- Insufficient Device Problem Information2
Patient problems
- Failure of Implant130
- No Clinical Signs, Symptoms or Conditions32
- Pain10
- Unspecified Infection10
- Abscess2
- Bone Fracture(s)2
- Implant Pain2
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 170 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263227 ↗InjuryAug 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263226 ↗InjuryJul 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25726615 ↗InjuryJul 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25726613 ↗InjuryMay 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25106974 ↗InjuryMay 6, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25106511 ↗InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24360427 ↗InjuryFeb 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24360425 ↗InjuryDec 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857097 ↗InjuryDec 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857095 ↗InjuryOct 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23387714 ↗InjuryOct 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23387713 ↗InjuryOct 16, 2025Osseointegration Problem; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23317308 ↗InjuryOct 16, 2025Osseointegration Problem; Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23317306 ↗InjuryOct 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23317267 ↗InjuryOct 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23317256 ↗InjurySep 5, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22984590 ↗InjurySep 5, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22984587 ↗InjuryAug 8, 2025Fracture; Fracture
IMPLANT FRACTURE AT IMPLANT PLACEMENT.
Patient problems: Unspecified Infection
MAUDE report 22764760 ↗InjuryAug 8, 2025Fracture; Fracture
IMPLANT FRACTURE AT IMPLANT PLACEMENT.
Patient problems: Unspecified Infection
MAUDE report 22764754 ↗InjuryAug 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22743892 ↗InjuryAug 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22743812 ↗InjuryAug 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22722496 ↗InjuryAug 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22722483 ↗MalfunctionJul 25, 2025Fracture; Fracture
COMPONENT FRACTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22614131 ↗
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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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