iSy Implants-SetRecalls & reported problems across all models
ALTATEC GmbH · 17 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 139
- Deaths reported
- 0
- Injuries reported
- 139
- Recalls
- 0
We found 17 models of iSy Implants-Set by ALTATEC GmbH in the FDA's device registry (GUDID). Together they are named in 139 adverse event reports in the FDA's MAUDE database, received between Feb 25, 2024 and Jul 9, 2026 — classified as 139 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (124 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported iSy Implants-Set problems
Device problems
- Failure to Osseointegrate124
- Use of Device Problem23
- Fracture2
- Device-Device Incompatibility1
- Loss of Osseointegration1
Patient problems
- Insufficient Information139
iSy Implants-Set models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- iSy® Implants-Set P1410.3809Implant, Endosseous, Root-Form38 reports
- iSy® Implants-Set P1410.3807Implant, Endosseous, Root-Form28 reports
- iSy® Implants-Set P1410.3811Implant, Endosseous, Root-Form18 reports
- iSy® Implants-Set P1410.4409Implant, Endosseous, Root-Form11 reports
- iSy® Implants-Set P1110.3809Implant, Endosseous, Root-Form7 reports
- iSy® Implants-Set P1110.3811Implant, Endosseous, Root-Form7 reports
- iSy® Implants-Set P1410.4407Implant, Endosseous, Root-Form5 reports
- iSy® Implants-Set P1410.3813Implant, Endosseous, Root-Form4 reports
- iSy® Implants-Set P1410.5009Implant, Endosseous, Root-Form4 reports
- iSy® Implants-Set P1110.3807Implant, Endosseous, Root-Form3 reports
- iSy® Implants-Set P1110.3813Implant, Endosseous, Root-Form3 reports
- iSy® Implants-Set P1110.4411Implant, Endosseous, Root-Form3 reports
- iSy® Implants-Set P1410.4411Implant, Endosseous, Root-Form3 reports
- iSy® Implants-Set P1410.5011Implant, Endosseous, Root-Form2 reports
- iSy® Implants-Set P1110.4409Implant, Endosseous, Root-Form1 report
- iSy® Implants-Set P1110.5009Implant, Endosseous, Root-Form1 report
- iSy® Implants-Set P1410.5007Implant, Endosseous, Root-Form1 report
Recent iSy Implants-Set adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 8, 2026Failure to Osseointegrate
InjuryJul 8, 2026Failure to Osseointegrate
InjuryJul 8, 2026Failure to Osseointegrate
InjuryJul 8, 2026Failure to Osseointegrate
InjuryJul 8, 2026Failure to Osseointegrate
InjuryJun 16, 2026Failure to Osseointegrate
InjuryJun 8, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25437699 ↗InjuryJun 5, 2026Failure to Osseointegrate
InjuryJun 5, 2026Failure to Osseointegrate
InjuryJun 5, 2026Failure to Osseointegrate
InjuryJun 3, 2026Failure to Osseointegrate
InjuryJun 3, 2026Failure to Osseointegrate
Other ALTATEC GmbH products
- CONELOG PROGRESSIVE-LINE Implant, Promote plus36 models · 977 reports
- CAMLOG SCREW-LINE Implant, Promote plus60 models · 628 reports
- CAMLOG PROGRESSIVE-LINE Implant, Promote plus24 models · 219 reports
- CONELOG SCREW-LINE Implant, Promote plus44 models · 194 reports
- CAMLOG SCREW-LINE Implant, Promote30 models · 80 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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