MEDTRONIC SOFAMOR DANEK

Manufacturer adverse-event records for MEDTRONIC SOFAMOR DANEK 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 · 2000–2020 · thin-book · elevated Death-code · injury-heavy

Volume signature

MEDTRONIC SOFAMOR DANEK is a thinner MAUDE footprint

MEDTRONIC SOFAMOR DANEK accounts for 4,420 FDA MAUDE reports (#383 of 443, thin-book tercile). Death-coded event_type share is 0.86% (elevated); Injury share 57.8% (injury-heavy).

What the volume reading shows for MEDTRONIC SOFAMOR DANEK

The standout signal for MEDTRONIC SOFAMOR DANEK is filing volume: 4,420 adverse-event reports in FDA MAUDE (#383 of 443, thin-book). Death-coded event_type share sits at 0.86% (elevated).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 20 device types, led in this extract by Injury at 2,553 (57.8% of event_type total). Peak single-year volume reaches 577 reports across 21 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,420
Total Reports
38
Event-type Death
2,553
Injury Reports
20
Device Types

Event Types

Injury 2,553 (57.8%)
Malfunction 1,746 (39.5%)
Other 42 (1.0%)
41 (0.9%)
Death 38 (0.9%)

Patient Outcomes

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

1,957 (41.4%)
Required Intervention 1,282 (27.1%)
Other 1,066 (22.6%)
R 267 (5.6%)
Hospitalization 58 (1.2%)
Death 39 (0.8%)
S 18 (0.4%)
O 13 (0.3%)
Disability 11 (0.2%)
L 6 (0.1%)
Life Threatening 6 (0.1%)
H 3 (0.1%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

00
2000: 2
01
2001: 4
02
2002: 4
03
2003: 4
04
2004: 6
05
2005: 6
06
2006: 13
07
2007: 43
08
2008: 125
09
2009: 384
10
2010: 466
11
2011: 390
12
2012: 239
13
2013: 577
14
2014: 492
15
2015: 495
16
2016: 522
17
2017: 402
18
2018: 192
19
2019: 50
20
2020: 4