IMPLANT DIRECT SYBRON MANUFACT

Manufacturer adverse-event records for IMPLANT DIRECT SYBRON MANUFACT 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 · 2023–2026 · mid-book · quiet Death-code · injury-heavy

Injury-mix signature

IMPLANT DIRECT SYBRON MANUFACT leans injury-heavy in event_type mix

Injury-coded event_type share is 99.2% (injury-heavy tercile) beside 0.02% Death-coded (quiet). Volume band: mid.

What the Injury-mix reading shows for IMPLANT DIRECT SYBRON MANUFACT

The standout signal for IMPLANT DIRECT SYBRON MANUFACT is Injury-mix: 99.2% Injury-coded (injury-heavy) beside 0.02% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for IMPLANT DIRECT SYBRON MANUFACT. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 1 device type, led in this extract by Injury at 12,385 (99.2% of event_type total). Peak single-year volume reaches 4,757 reports across 4 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

12,480
Total Reports
3
Event-type Death
12,385
Injury Reports
1
Device Types

Event Types

Injury 12,385 (99.2%)
Malfunction 92 (0.7%)
Death 3 (0.0%)

Patient Outcomes

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

Required Intervention 12,417 (99.6%)
Other 31 (0.2%)
R 17 (0.1%)
Death 3 (0.0%)
H 1 (0.0%)

Devices (1)

Device Reports
Implant, Endosseous, Root-Form 12,480

Yearly Trend

23
2023: 463
24
2024: 4,757
25
2025: 4,563
26
2026: 2,697