INSTITUT STRAUMANN AG

FDA MAUDE device safety record · 1996–2026

What the Data Shows About INSTITUT STRAUMANN AG

INSTITUT STRAUMANN AG is associated with 1,087,606 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1996 through 2026. Of the total, 1 is coded as a death report and 1,087,595 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 13 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for INSTITUT STRAUMANN AG should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Injury at 1,087,595 reports (100.0% of total). Patient-outcome categorizations are reported across 9 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 19 years of MAUDE data, with the peak single-year volume reaching 233,761 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

1,087,606
Total Reports
1
Death Reports
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

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

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.