Z5m(t) Z5m(t)-50-12Recalls & reported problems
Z-Systems AG · Monotype root-form dental implant made of Zirconia Familiy Z5m(t) Size Z5m(t)-50-12 · 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 screw placed in the jaw to support a tooth replacement. The 58 reports mostly describe the implant failing to fuse with the surrounding bone or losing that bond after surgery, along with tissue damage, infection, and inflammation around the implant. All reports describe injuries, with no deaths and no malfunctions. There are no recalls naming this device, and report numbers were the same in the last 12 months as the prior 12 months.
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
- 58
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 07640166760559), received between Aug 31, 2020 and Aug 21, 2024 — classified as 58 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (43 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 Osseointegrate43
- Loss of Osseointegration15
Patient problems
- Unspecified Tissue Injury41
- Tissue Damage17
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 27, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJul 18, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 7, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryApr 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 24, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 30, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 9, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 9, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 15, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT DID NOT INTEGRATE TO BONE.
Patient problems: Unspecified Tissue Injury
MAUDE report 12171872 ↗InjuryJul 15, 2021Loss of Osseointegration; Loss of Osseointegration
IMPLANT DID NOT INTEGRATE TO BONE: PATIENT CAME WITH LOOSE IMPLANT 3 MONTHS POST FINAL RESTORATION.
Patient problems: Unspecified Tissue Injury
MAUDE report 12171868 ↗InjuryJul 14, 2021Loss of Osseointegration; Loss of Osseointegration
THE IMPLANT FAILED IN INITIAL 4 WEEKS HEALING. TRAUMA/ACCIDENT. SIGNS OF INFLAMATION.
Patient problems: Unspecified Tissue Injury
MAUDE report 12164868 ↗InjuryJul 14, 2021Failure to Osseointegrate; Failure to Osseointegrate
AFTER 8 MONTHS THE IMPLANT IS STILL LOOSE.
Patient problems: Unspecified Tissue Injury
MAUDE report 12164858 ↗InjuryJul 14, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DID NOT INTAGRATE TO BONE.
Patient problems: Unspecified Tissue Injury
MAUDE report 12164799 ↗InjuryJul 14, 2021Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DID NOT INTAGRATE TO BONE.
Patient problems: Unspecified Tissue Injury
MAUDE report 12164798 ↗InjuryJun 15, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 15, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 6, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 29, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryMar 19, 2021Failure 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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