iSy® Implants-Set P1410.3809Recalls & reported problems
ALTATEC GmbH · P1410.3809 iSy® Implants-Set, 4 units d 3.8 mm, L 9 mm · Class 2 · Implant
Quick summary
This ALTATEC iSy dental implant set is a screw-shaped implant used to anchor replacement teeth in the jawbone. The 38 reports mostly describe implants that fail to fuse with the bone, so they loosen and have to be taken out, sometimes within days of placement; a couple of reports mention the implant breaking. There are 38 injuries and no deaths, 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
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI E219P141038091), received between Feb 28, 2024 and Jul 8, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (34 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate34
- Use of Device Problem4
- Fracture2
Patient problems
- Insufficient Information38
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Failure to Osseointegrate
InjuryJun 3, 2026Failure to Osseointegrate
InjuryJun 3, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25380390 ↗InjuryMay 29, 2026Failure to Osseointegrate
InjuryMay 20, 2026Failure to Osseointegrate
InjuryMay 20, 2026Failure to Osseointegrate
InjuryMay 15, 2026Failure to Osseointegrate
InjuryMay 8, 2026Failure to Osseointegrate
InjuryDec 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 19, 2025Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate
InjuryDec 19, 2025Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate
InjuryDec 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 15, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22819605 ↗InjuryJul 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 11, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS
Patient problems: Insufficient Information
MAUDE report 21577339 ↗InjuryFeb 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 9, 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.