STRYKER MEDICAL-KALAMAZOO

FDA MAUDE device safety record · 2013–2026

What the Data Shows About STRYKER MEDICAL-KALAMAZOO

STRYKER MEDICAL-KALAMAZOO is associated with 29,006 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2013 through 2026. Of the total, 102 are coded as death reports and 1,143 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 MEDICAL-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 27,761 reports (95.7% 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 14 years of MAUDE data, with the peak single-year volume reaching 12,898 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.

29,006
Total Reports
102
Death Reports
1,143
Injury Reports
20
Device Types

Event Types

Malfunction 27,761 (95.7%)
Injury 1,143 (3.9%)
Death 102 (0.4%)

Patient Outcomes

28,401 (97.9%)
Other 490 (1.7%)
Death 62 (0.2%)
Required Intervention 24 (0.1%)
Hospitalization 11 (0.0%)
Disability 6 (0.0%)
Life Threatening 5 (0.0%)
O 4 (0.0%)
H 2 (0.0%)
R 2 (0.0%)
S 2 (0.0%)
D 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

13
2013: 12,898
14
2014: 3,482
15
2015: 646
16
2016: 424
17
2017: 596
18
2018: 1,455
19
2019: 1,217
20
2020: 1,228
21
2021: 1,627
22
2022: 1,237
23
2023: 1,375
24
2024: 1,428
25
2025: 1,231
26
2026: 162

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.