BETA BIONICS INC.

Manufacturer adverse-event records for BETA BIONICS INC. 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 · balanced

Volume signature

BETA BIONICS INC. sits in the heavy MAUDE book

BETA BIONICS INC. accounts for 37,341 FDA MAUDE reports (#100 of 434, heavy-book tercile). Death-coded event_type share is 0.03% (quiet); Injury share 17.9% (balanced).

What the volume reading shows for BETA BIONICS INC.

The standout signal for BETA BIONICS INC. is filing volume: 37,341 adverse-event reports in FDA MAUDE (#100 of 434, heavy-book). Death-coded event_type share sits at 0.03% (quiet).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair BETA BIONICS INC. 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 2 device types, led in this extract by Malfunction at 30,657 (82.1% of event_type total). Peak single-year volume reaches 24,642 reports across 3 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

37,341
Total Reports
13
Event-type Death
6,671
Injury Reports
2
Device Types

Event Types

Malfunction 30,657 (82.1%)
Injury 6,671 (17.9%)
Death 13 (0.0%)

Patient Outcomes

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

28,569 (75.8%)
Other 3,679 (9.8%)
Required Intervention 3,479 (9.2%)
Life Threatening 1,099 (2.9%)
Hospitalization 497 (1.3%)
R 187 (0.5%)
O 159 (0.4%)
H 23 (0.1%)
Death 11 (0.0%)
L 7 (0.0%)
Disability 3 (0.0%)
D 1 (0.0%)

Yearly Trend

24
2024: 1
25
2025: 12,698
26
2026: 24,642