STRYKER INSTRUMENTS-KALAMAZOO

FDA MAUDE device safety record · 2013–2025

What the Data Shows About STRYKER INSTRUMENTS-KALAMAZOO

STRYKER INSTRUMENTS-KALAMAZOO is associated with 29,458 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2013 through 2025. Of the total, 7 are coded as death reports and 658 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 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for STRYKER INSTRUMENTS-KALAMAZOO should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Malfunction at 28,793 reports (97.7% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 13 years of MAUDE data, with the peak single-year volume reaching 4,738 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.

29,458
Total Reports
7
Death Reports
658
Injury Reports
20
Device Types

Event Types

Malfunction 28,793 (97.7%)
Injury 658 (2.2%)
Death 7 (0.0%)

Patient Outcomes

28,808 (97.8%)
Other 344 (1.2%)
Required Intervention 259 (0.9%)
R 21 (0.1%)
Hospitalization 13 (0.0%)
Death 12 (0.0%)
Disability 3 (0.0%)
L 2 (0.0%)
S 2 (0.0%)
Life Threatening 2 (0.0%)
D 1 (0.0%)
O 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

13
2013: 3,301
14
2014: 4,638
15
2015: 4,738
16
2016: 2,832
17
2017: 2,394
18
2018: 2,825
19
2019: 4,067
20
2020: 3,395
21
2021: 818
22
2022: 143
23
2023: 286
24
2024: 18
25
2025: 3

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.