Z5m(t) Z5m(t)-50-10Recalls & reported problems
Z-Systems AG · Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-50-10 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Z-Systems Z5m zirconia dental implant is a root-form implant placed into the jawbone. Most of the 56 reports describe the implant failing to fuse with the surrounding bone or later losing that connection, along with tissue damage around the site; a few mention the abutment part fracturing so the implant had to be removed. 54 injuries and no deaths were reported, with no recalls naming 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
- 56
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 07640166760542), received between Aug 31, 2020 and Apr 30, 2025 — classified as 54 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (42 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 Osseointegrate42
- Loss of Osseointegration14
Patient problems
- Unspecified Tissue Injury43
- Tissue Damage11
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT/ POOR BONE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21932503 ↗MalfunctionMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-OSSEOINTEGRATION DUE TO INSUFFICIENT BONE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631763 ↗InjuryAug 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE ABUTMENT PART OF THE ONE-PIECE IMPLANT FRACTURED, SO THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Tissue Injury
MAUDE report 20065130 ↗InjuryAug 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
INSUFFICIENT BONE QUALITY + QUANTITY.
Patient problems: Unspecified Tissue Injury
MAUDE report 20029314 ↗InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 1, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJul 18, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 19, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryDec 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 19, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryNov 29, 2022Failure to Osseointegrate; Failure to Osseointegrate
CAUSE TRACED TO USER, OVER-TORQUED.
Patient problems: Unspecified Tissue Injury
MAUDE report 15876470 ↗InjuryOct 14, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 9, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 11, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 19, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 19, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 9, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 30, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 9, 2021Loss of Osseointegration; Loss of Osseointegration
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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