STRYKER MEDICAL

FDA MAUDE device safety record · 1993–2026

What the Data Shows About STRYKER MEDICAL

STRYKER MEDICAL is associated with 26,306 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1993 through 2026. Of the total, 24 are coded as death reports and 320 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 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 Malfunction at 25,684 reports (97.6% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 33 years of MAUDE data, with the peak single-year volume reaching 12,767 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.

26,306
Total Reports
24
Death Reports
320
Injury Reports
20
Device Types

Event Types

Malfunction 25,684 (97.6%)
Injury 320 (1.2%)
Other 189 (0.7%)
89 (0.3%)
Death 24 (0.1%)

Patient Outcomes

26,031 (98.9%)
Other 197 (0.7%)
Required Intervention 32 (0.1%)
Hospitalization 20 (0.1%)
Death 17 (0.1%)
O 10 (0.0%)
R 5 (0.0%)
Disability 5 (0.0%)
H 3 (0.0%)
Life Threatening 3 (0.0%)
C 1 (0.0%)
L 1 (0.0%)
S 1 (0.0%)
Invalid Data 1 (0.0%)

Yearly Trend

93
1993: 1
94
1994: 2
96
1996: 2
97
1997: 2
98
1998: 2
99
1999: 3
00
2000: 4
01
2001: 7
02
2002: 6
03
2003: 8
04
2004: 9
05
2005: 17
06
2006: 11
07
2007: 13
08
2008: 16
09
2009: 25
10
2010: 19
11
2011: 12,767
12
2012: 12,278
13
2013: 582
14
2014: 15
15
2015: 17
16
2016: 5
17
2017: 10
18
2018: 14
19
2019: 12
20
2020: 4
21
2021: 7
22
2022: 3
23
2023: 4
24
2024: 408
25
2025: 31
26
2026: 2

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.