Z-SYSTEMS AG

Manufacturer adverse-event records for Z-SYSTEMS AG 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 · 2012–2026 · thin-book · quiet Death-code · injury-heavy

Volume signature

Z-SYSTEMS AG is a thinner MAUDE footprint

Z-SYSTEMS AG accounts for 3,887 FDA MAUDE reports (#424 of 434, thin-book tercile). Death-coded event_type share is 0.00% (quiet); Injury share 88.1% (injury-heavy).

What the volume reading shows for Z-SYSTEMS AG

The standout signal for Z-SYSTEMS AG is filing volume: 3,887 adverse-event reports in FDA MAUDE (#424 of 434, thin-book). Death-coded event_type share sits at 0.00% (quiet).

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 2 device types, led in this extract by Injury at 3,425 (88.1% of event_type total). Peak single-year volume reaches 509 reports across 14 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

3,887
Total Reports
0
Event-type Death
3,425
Injury Reports
2
Device Types

Event Types

Injury 3,425 (88.1%)
Malfunction 457 (11.8%)
Other 5 (0.1%)

Patient Outcomes

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

Other 1,848 (44.4%)
Disability 1,779 (42.7%)
S 280 (6.7%)
228 (5.5%)
O 12 (0.3%)
Death 6 (0.1%)
Congenital Anomaly 5 (0.1%)
D 4 (0.1%)
H 1 (0.0%)
Life Threatening 1 (0.0%)

Yearly Trend

12
2012: 14
13
2013: 74
15
2015: 323
16
2016: 286
17
2017: 331
18
2018: 279
19
2019: 70
20
2020: 408
21
2021: 509
22
2022: 307
23
2023: 351
24
2024: 441
25
2025: 285
26
2026: 209