SYNTHES BRANDYWINE

Manufacturer adverse-event records for SYNTHES BRANDYWINE 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 · 2008–2025 · thin-book · typical Death-code · injury-heavy

Volume signature

SYNTHES BRANDYWINE is a thinner MAUDE footprint

SYNTHES BRANDYWINE accounts for 5,581 FDA MAUDE reports (#341 of 443, thin-book tercile). Death-coded event_type share is 0.59% (typical); Injury share 59.2% (injury-heavy).

What the volume reading shows for SYNTHES BRANDYWINE

The standout signal for SYNTHES BRANDYWINE is filing volume: 5,581 adverse-event reports in FDA MAUDE (#341 of 443, thin-book). Death-coded event_type share sits at 0.59% (typical).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 20 device types, led in this extract by Injury at 3,302 (59.2% of event_type total). Peak single-year volume reaches 1,390 reports across 15 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,581
Total Reports
33
Event-type Death
3,302
Injury Reports
20
Device Types

Event Types

Injury 3,302 (59.2%)
Malfunction 2,240 (40.1%)
Death 33 (0.6%)
6 (0.1%)

Patient Outcomes

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

Required Intervention 3,187 (57.0%)
2,348 (42.0%)
Death 33 (0.6%)
R 11 (0.2%)
Other 6 (0.1%)
Disability 4 (0.1%)
Hospitalization 3 (0.1%)
S 1 (0.0%)

Yearly Trend

08
2008: 54
09
2009: 139
10
2010: 227
11
2011: 302
12
2012: 1,114
13
2013: 1,390
14
2014: 612
15
2015: 910
16
2016: 428
17
2017: 381
19
2019: 4
22
2022: 4
23
2023: 9
24
2024: 4
25
2025: 3