S.I.N. IMPLANT SYSTEM

Manufacturer adverse-event records for S.I.N. IMPLANT SYSTEM come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2024–2026 · heavy-book · quiet Death-code · injury-heavy

Injury-mix signature

S.I.N. IMPLANT SYSTEM leans injury-heavy in event_type mix

Injury-coded event_type share is 100.0% (injury-heavy tercile) beside 0.00% Death-coded (quiet). Volume band: heavy.

What the Injury-mix reading shows for S.I.N. IMPLANT SYSTEM

The standout signal for S.I.N. IMPLANT SYSTEM is Injury-mix: 100.0% Injury-coded (injury-heavy) beside 0.00% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair S.I.N. IMPLANT SYSTEM with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 1 device type, led in this extract by Injury at 28,296 (100.0% of event_type total). Peak single-year volume reaches 13,648 reports across 3 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

28,296
Total Reports
0
Event-type Death
28,296
Injury Reports
1
Device Types

Event Types

Injury 28,296 (100.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 28,292 (100.0%)
R 5 (0.0%)
Death 3 (0.0%)
D 1 (0.0%)

Devices (1)

Device Reports
Implant, Endosseous, Root-Form 28,296

Yearly Trend

24
2024: 12,098
25
2025: 13,648
26
2026: 2,550