ORTHO-CLINICAL DIAGNOSTICS

Manufacturer adverse-event records for ORTHO-CLINICAL DIAGNOSTICS come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 1997–2024 · mid-book · quiet Death-code · injury-light

Death-code intensity

ORTHO-CLINICAL DIAGNOSTICS is quieter on Death-coded events

Death-coded event_type rows are 0 of 11,184 (0.00% · quiet tercile among 443 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for ORTHO-CLINICAL DIAGNOSTICS

The standout signal for ORTHO-CLINICAL DIAGNOSTICS is Death-code intensity: 0.00% of 11,184 reports (quiet tercile), while absolute volume is mid-book.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for ORTHO-CLINICAL DIAGNOSTICS. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Malfunction at 11,065 (98.9% of event_type total). Peak single-year volume reaches 847 reports across 28 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

11,184
Total Reports
0
Event-type Death
70
Injury Reports
20
Device Types

Event Types

Malfunction 11,065 (98.9%)
Injury 70 (0.6%)
Other 39 (0.3%)
10 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

10,356 (92.6%)
Other 809 (7.2%)
Hospitalization 13 (0.1%)
O 3 (0.0%)
Required Intervention 3 (0.0%)
R 1 (0.0%)

Yearly Trend

97
1997: 4
98
1998: 22
99
1999: 94
00
2000: 57
01
2001: 53
02
2002: 348
03
2003: 715
04
2004: 332
05
2005: 274
06
2006: 288
07
2007: 492
08
2008: 415
09
2009: 475
10
2010: 423
11
2011: 700
12
2012: 847
13
2013: 821
14
2014: 577
15
2015: 677
16
2016: 606
17
2017: 505
18
2018: 533
19
2019: 464
20
2020: 562
21
2021: 507
22
2022: 373
23
2023: 10
24
2024: 10