Z5m(t) Z5m(t)-50-08Recalls & reported problems
Z-Systems AG · Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-50-08 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5m(t) zirconia dental implant is a root-form implant placed in the jawbone. Most of the 32 reports describe the implant failing to fuse with the surrounding bone, along with tissue damage around the implant site and inflammation of the gum and bone. There have been no deaths, 31 injuries and 1 malfunction, and 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
- 32
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07640166760535), received between Aug 31, 2020 and Jan 22, 2026 — classified as 31 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (17 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
- Loss of Osseointegration17
- Failure to Osseointegrate15
Patient problems
- Unspecified Tissue Injury22
- Tissue Damage9
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24148781 ↗InjuryOct 24, 2024Loss of Osseointegration; Loss of Osseointegration
BIOMECHANICAL OVERLOAD: AFTER DEF. PROSTHETIC RESTORATION
Patient problems: Unspecified Tissue Injury
MAUDE report 20520113 ↗InjurySep 22, 2023Loss of Osseointegration; Loss of Osseointegration
InjurySep 22, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 24, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 18, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJul 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryDec 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 29, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryMar 9, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryJan 13, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryJul 22, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT DID NOT INEGRATE TO BONE DUE TO BIOMECHANICAL OVERLOAD.
Patient problems: Unspecified Tissue Injury
MAUDE report 12210113 ↗InjuryMar 29, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 19, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 19, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryMar 19, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryMar 19, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryMar 19, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 8, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 8, 2021Failure to Osseointegrate; Failure to Osseointegrate
PROBLEMS OF OSSEINTEGRATION CAUSED OF TISSUE AROUND IMPLANT.
Patient problems: Unspecified Tissue Injury
MAUDE report 11291859 ↗InjuryOct 20, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 20, 2020Failure 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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