SYNTHES GMBH

Manufacturer adverse-event records for SYNTHES GMBH 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 · 2008–2026 · heavy-book · quiet Death-code · balanced

Volume signature

SYNTHES GMBH sits in the heavy MAUDE book

SYNTHES GMBH accounts for 79,650 FDA MAUDE reports (#44 of 434, heavy-book tercile). Death-coded event_type share is 0.06% (quiet); Injury share 26.0% (balanced).

What the volume reading shows for SYNTHES GMBH

The standout signal for SYNTHES GMBH is filing volume: 79,650 adverse-event reports in FDA MAUDE (#44 of 434, heavy-book). Death-coded event_type share sits at 0.06% (quiet).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair SYNTHES GMBH 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 20 device types, led in this extract by Malfunction at 58,898 (73.9% of event_type total). Peak single-year volume reaches 14,070 reports across 17 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

79,650
Total Reports
44
Event-type Death
20,700
Injury Reports
20
Device Types

Event Types

Malfunction 58,898 (73.9%)
Injury 20,700 (26.0%)
Death 44 (0.1%)
8 (0.0%)

Patient Outcomes

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

58,186 (74.0%)
Required Intervention 19,881 (25.3%)
Other 346 (0.4%)
R 59 (0.1%)
Death 39 (0.0%)
O 20 (0.0%)
S 16 (0.0%)
Hospitalization 16 (0.0%)
D 6 (0.0%)
H 6 (0.0%)
L 5 (0.0%)
Congenital Anomaly 5 (0.0%)
Life Threatening 5 (0.0%)
Disability 3 (0.0%)

Yearly Trend

08
2008: 1
09
2009: 1
11
2011: 356
12
2012: 1,719
13
2013: 6,105
14
2014: 1,749
15
2015: 1
16
2016: 1
18
2018: 8
19
2019: 9
20
2020: 1,361
21
2021: 9,907
22
2022: 10,971
23
2023: 14,070
24
2024: 13,546
25
2025: 12,567
26
2026: 7,278