STRYKER TRAUMA KIEL

FDA MAUDE device safety record · 2004–2025

What the Data Shows About STRYKER TRAUMA KIEL

STRYKER TRAUMA KIEL is associated with 7,824 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2004 through 2025. Of the total, 70 are coded as death reports and 5,315 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 TRAUMA KIEL 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 Injury at 5,315 reports (67.9% 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 19 years of MAUDE data, with the peak single-year volume reaching 1,495 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.

7,824
Total Reports
70
Death Reports
5,315
Injury Reports
20
Device Types

Event Types

Injury 5,315 (67.9%)
Malfunction 2,439 (31.2%)
Death 70 (0.9%)

Patient Outcomes

Required Intervention 3,986 (48.9%)
Other 2,530 (31.0%)
922 (11.3%)
R 295 (3.6%)
Death 262 (3.2%)
Hospitalization 82 (1.0%)
Disability 28 (0.3%)
H 16 (0.2%)
S 16 (0.2%)
O 12 (0.1%)
Life Threatening 4 (0.0%)
Congenital Anomaly 3 (0.0%)
L 2 (0.0%)
D 1 (0.0%)

Yearly Trend

04
2004: 12
05
2005: 57
06
2006: 80
07
2007: 38
08
2008: 1
09
2009: 1
13
2013: 272
14
2014: 709
15
2015: 506
16
2016: 633
17
2017: 387
18
2018: 1,495
19
2019: 983
20
2020: 1,086
21
2021: 833
22
2022: 593
23
2023: 135
24
2024: 1
25
2025: 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.