MEDTRONIC SOFAMOR DANEK USA, INC

Manufacturer adverse-event records for MEDTRONIC SOFAMOR DANEK USA, INC 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 · 2006–2026 · mid-book · typical Death-code · injury-heavy

Injury-mix signature

MEDTRONIC SOFAMOR DANEK USA, INC leans injury-heavy in event_type mix

Injury-coded event_type share is 61.3% (injury-heavy tercile) beside 0.24% Death-coded (typical). Volume band: mid.

What the Injury-mix reading shows for MEDTRONIC SOFAMOR DANEK USA, INC

The standout signal for MEDTRONIC SOFAMOR DANEK USA, INC is Injury-mix: 61.3% Injury-coded (injury-heavy) beside 0.24% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for MEDTRONIC SOFAMOR DANEK USA, INC. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Injury at 12,503 (61.3% of event_type total). Peak single-year volume reaches 3,586 reports across 20 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

20,388
Total Reports
48
Event-type Death
12,503
Injury Reports
20
Device Types

Event Types

Injury 12,503 (61.3%)
Malfunction 7,794 (38.2%)
Death 48 (0.2%)
43 (0.2%)

Patient Outcomes

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

Other 8,830 (41.3%)
8,038 (37.6%)
Required Intervention 3,254 (15.2%)
R 837 (3.9%)
Hospitalization 144 (0.7%)
O 61 (0.3%)
S 61 (0.3%)
Death 48 (0.2%)
Life Threatening 41 (0.2%)
Disability 21 (0.1%)
H 19 (0.1%)
L 8 (0.0%)
Congenital Anomaly 3 (0.0%)

Yearly Trend

06
2006: 1
08
2008: 1
09
2009: 1
10
2010: 51
11
2011: 281
12
2012: 1,861
13
2013: 3,586
14
2014: 2,374
15
2015: 2,105
16
2016: 1,804
17
2017: 1,089
18
2018: 567
19
2019: 548
20
2020: 771
21
2021: 882
22
2022: 649
23
2023: 466
24
2024: 1,353
25
2025: 1,986
26
2026: 12