SYNTHES MONUMENT

Manufacturer adverse-event records for SYNTHES MONUMENT 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 · 2007–2018 · mid-book · typical Death-code · balanced

Injury-mix signature

SYNTHES MONUMENT keeps a balanced Injury share

Injury-coded event_type share is 42.8% (balanced tercile) beside 0.20% Death-coded (typical). Volume band: mid.

What the Injury-mix reading shows for SYNTHES MONUMENT

The standout signal for SYNTHES MONUMENT is Injury-mix: 42.8% Injury-coded (balanced) beside 0.20% Death-coded, on a mid-book footprint.

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

Reports span 20 device types, led in this extract by Malfunction at 5,044 (56.9% of event_type total). Peak single-year volume reaches 2,079 reports across 12 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

8,869
Total Reports
18
Event-type Death
3,792
Injury Reports
20
Device Types

Event Types

Malfunction 5,044 (56.9%)
Injury 3,792 (42.8%)
Death 18 (0.2%)
15 (0.2%)

Patient Outcomes

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

5,130 (57.8%)
Required Intervention 3,702 (41.7%)
Death 21 (0.2%)
Other 10 (0.1%)
R 7 (0.1%)
S 6 (0.1%)
Hospitalization 5 (0.1%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

07
2007: 5
08
2008: 110
09
2009: 112
10
2010: 338
11
2011: 639
12
2012: 1,430
13
2013: 2,079
14
2014: 907
15
2015: 954
16
2016: 1,018
17
2017: 1,266
18
2018: 11