MDT SOFAMOR DANEK PUERTO RICO MFG

Manufacturer adverse-event records for MDT SOFAMOR DANEK PUERTO RICO MFG 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 · 2008–2025 · thin-book · typical Death-code · balanced

Volume signature

MDT SOFAMOR DANEK PUERTO RICO MFG is a thinner MAUDE footprint

MDT SOFAMOR DANEK PUERTO RICO MFG accounts for 6,786 FDA MAUDE reports (#300 of 443, thin-book tercile). Death-coded event_type share is 0.21% (typical); Injury share 44.5% (balanced).

What the volume reading shows for MDT SOFAMOR DANEK PUERTO RICO MFG

The standout signal for MDT SOFAMOR DANEK PUERTO RICO MFG is filing volume: 6,786 adverse-event reports in FDA MAUDE (#300 of 443, thin-book). Death-coded event_type share sits at 0.21% (typical).

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 Malfunction at 3,742 (55.1% of event_type total). Peak single-year volume reaches 918 reports across 18 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

6,786
Total Reports
14
Event-type Death
3,023
Injury Reports
20
Device Types

Event Types

Malfunction 3,742 (55.1%)
Injury 3,023 (44.5%)
Death 14 (0.2%)
7 (0.1%)

Patient Outcomes

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

3,608 (49.6%)
Required Intervention 2,427 (33.3%)
Other 564 (7.7%)
R 418 (5.7%)
Hospitalization 143 (2.0%)
H 40 (0.5%)
O 19 (0.3%)
Death 14 (0.2%)
Disability 13 (0.2%)
L 11 (0.2%)
S 10 (0.1%)
Life Threatening 10 (0.1%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

08
2008: 1
09
2009: 5
10
2010: 4
11
2011: 45
12
2012: 377
13
2013: 603
14
2014: 499
15
2015: 615
16
2016: 918
17
2017: 615
18
2018: 514
19
2019: 452
20
2020: 548
21
2021: 428
22
2022: 301
23
2023: 240
24
2024: 314
25
2025: 307