NobelZygoma™ 38285 (UDI 07332747102758)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 NobelZygoma dental implant is a root-form screw placed in the jawbone to anchor a tooth replacement. The 53 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that bond after surgery, along with occasional breakage, shifting in the jaw, pain, and sinus perforation. There are no deaths, and 53 reports describe injuries. No recalls name this device. Reports fell sharply, from 14 in the earlier 12 months to 2 in the most recent.
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
- 53
- Deaths reported
- 0
- Injuries reported
- 53
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 07332747102758), received between Sep 14, 2019 and Dec 5, 2025 — classified as 53 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (29 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 Osseointegrate29
- Loss of Osseointegration12
- Osseointegration Problem8
- Fracture2
- Migration2
Patient problems
- Failure of Implant43
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Pain4
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
- Sinus Perforation2
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23734700 ↗InjuryDec 5, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23734697 ↗InjuryAug 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22900147 ↗InjuryAug 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22900116 ↗InjuryJul 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22442620 ↗InjuryJul 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22442615 ↗InjuryJul 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22442589 ↗InjuryJul 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22442567 ↗InjuryMar 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 26, 2025Osseointegration Problem; Osseointegration Problem
InjuryFeb 26, 2025Osseointegration Problem; Osseointegration Problem
InjuryFeb 26, 2025Osseointegration Problem; Osseointegration Problem
InjuryFeb 26, 2025Osseointegration Problem; Osseointegration Problem
InjuryFeb 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 13, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19533053 ↗InjuryJun 13, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 19532661 ↗InjuryNov 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18134216 ↗InjuryNov 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18134212 ↗InjuryNov 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18134144 ↗InjuryNov 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18134138 ↗InjuryNov 6, 2023Migration; Migration
InjuryNov 6, 2023Migration; Migration
InjuryOct 2, 2023Fracture; Fracture
IMPLANT FAILED DUE TO THE IMPLANT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 17854997 ↗
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- 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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