ALTATEC GMBH

Manufacturer adverse-event records for ALTATEC 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 · 2005–2026 · heavy-book · quiet Death-code · injury-heavy

Injury-mix signature

ALTATEC GMBH leans injury-heavy in event_type mix

Injury-coded event_type share is 100.0% (injury-heavy tercile) beside 0.00% Death-coded (quiet). Volume band: heavy.

What the Injury-mix reading shows for ALTATEC GMBH

The standout signal for ALTATEC GMBH is Injury-mix: 100.0% Injury-coded (injury-heavy) beside 0.00% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ALTATEC 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 2 device types, led in this extract by Injury at 79,288 (100.0% of event_type total). Peak single-year volume reaches 19,202 reports across 12 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

79,292
Total Reports
1
Event-type Death
79,288
Injury Reports
2
Device Types

Event Types

Injury 79,288 (100.0%)
Malfunction 3 (0.0%)
Death 1 (0.0%)

Patient Outcomes

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

Required Intervention 78,916 (98.9%)
R 275 (0.3%)
Other 192 (0.2%)
O 191 (0.2%)
L 76 (0.1%)
Life Threatening 74 (0.1%)
26 (0.0%)
Hospitalization 10 (0.0%)
H 3 (0.0%)

Yearly Trend

05
2005: 4
07
2007: 52
08
2008: 11
18
2018: 4
19
2019: 40
20
2020: 525
21
2021: 19,202
22
2022: 12,152
23
2023: 13,057
24
2024: 16,355
25
2025: 15,064
26
2026: 2,826