Z5m Z5m-36-10Recalls & reported problems
Z-Systems AG · Monotype root-form dental implant made of Zirconia Familiy Z5m Size Z5m-36-10 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5m root-form dental implant is a zirconia screw placed into the jawbone to support a tooth. The 55 reports mostly describe the implant failing to fuse with the bone, or losing that bond once it had formed, along with tissue injury and inflammation around the site. Reports include 38 injuries and no deaths. 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
- 55
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 07640166769491), received between Aug 25, 2022 and Aug 26, 2026 — classified as 38 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (44 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 Osseointegrate44
- Loss of Osseointegration11
Patient problems
- Unspecified Tissue Injury36
- Inflammation9
- No Clinical Signs, Symptoms or Conditions9
- Implant Pain1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Failure to Osseointegrate
InjuryAug 26, 2026Loss of Osseointegration
loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50450475 ↗MalfunctionJun 24, 2026Failure to Osseointegrate
MalfunctionJun 24, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25608893 ↗MalfunctionMay 26, 2026Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25276639 ↗MalfunctionMar 26, 2026Failure to Osseointegrate
MalfunctionJan 22, 2026Failure to Osseointegrate
MalfunctionJan 22, 2026Failure to Osseointegrate
MalfunctionDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionDec 17, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301753 ↗MalfunctionOct 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278065 ↗MalfunctionAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22893686 ↗MalfunctionAug 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT/ POOR BONE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22873113 ↗MalfunctionAug 22, 2025Loss of Osseointegration; Loss of Osseointegration
MalfunctionAug 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22872920 ↗MalfunctionApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON OSSEOINTEGRATION DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932532 ↗MalfunctionApr 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
MalfunctionApr 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION DUE TO BIOMECHANICAL OVERLOAD + INFECTION.
Patient problems: Unspecified Tissue Injury
MAUDE report 21433291 ↗InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT/ POOR BONE QUALITY
Patient problems: Unspecified Tissue Injury
MAUDE report 20254815 ↗InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON OSSEOINTEGRATION DUE TO PERI-IMPLANTITIS.
Patient problems: Unspecified Tissue Injury
MAUDE report 20254813 ↗InjuryAug 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryAug 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
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.
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