INSTITUT STRAUMANN AG

Manufacturer adverse-event records for INSTITUT STRAUMANN 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 · 1996–2026 · heavy-book · quiet Death-code · injury-heavy

Volume signature

INSTITUT STRAUMANN AG sits in the heavy MAUDE book

INSTITUT STRAUMANN AG accounts for 1,087,606 FDA MAUDE reports (#5 of 443, heavy-book tercile). Death-coded event_type share is 0.00% (quiet); Injury share 100.0% (injury-heavy).

What the volume reading shows for INSTITUT STRAUMANN AG

The standout signal for INSTITUT STRAUMANN AG is filing volume: 1,087,606 adverse-event reports in FDA MAUDE (#5 of 443, heavy-book). Death-coded event_type share sits at 0.00% (quiet).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair INSTITUT STRAUMANN AG 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 13 device types, led in this extract by Injury at 1,087,595 (100.0% of event_type total). Peak single-year volume reaches 233,761 reports across 19 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

1,087,606
Total Reports
1
Event-type Death
1,087,595
Injury Reports
13
Device Types

Event Types

Injury 1,087,595 (100.0%)
4 (0.0%)
Other 4 (0.0%)
Malfunction 2 (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 1,085,067 (99.9%)
R 563 (0.1%)
Life Threatening 79 (0.0%)
S 22 (0.0%)
Hospitalization 20 (0.0%)
Other 13 (0.0%)
12 (0.0%)
Congenital Anomaly 2 (0.0%)
Death 1 (0.0%)

Yearly Trend

96
1996: 110
97
1997: 286
01
2001: 1
02
2002: 3
04
2004: 1
05
2005: 1
07
2007: 1
11
2011: 31
12
2012: 8
14
2014: 1
18
2018: 747
19
2019: 71,337
20
2020: 95,064
21
2021: 110,569
22
2022: 149,062
23
2023: 178,599
24
2024: 212,026
25
2025: 233,761
26
2026: 35,998