NOBEL BIOCARE USA, LLC

Manufacturer adverse-event records for NOBEL BIOCARE USA, LLC 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 · 2005–2026 · mid-book · quiet Death-code · injury-heavy

Injury-mix signature

NOBEL BIOCARE USA, LLC leans injury-heavy in event_type mix

Injury-coded event_type share is 99.8% (injury-heavy tercile) beside 0.00% Death-coded (quiet). Volume band: mid.

What the Injury-mix reading shows for NOBEL BIOCARE USA, LLC

The standout signal for NOBEL BIOCARE USA, LLC is Injury-mix: 99.8% Injury-coded (injury-heavy) beside 0.00% Death-coded, on a mid-book footprint.

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

Reports span 4 device types, led in this extract by Injury at 20,036 (99.8% of event_type total). Peak single-year volume reaches 12,661 reports across 15 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

20,069
Total Reports
0
Event-type Death
20,036
Injury Reports
4
Device Types

Event Types

Injury 20,036 (99.8%)
Malfunction 32 (0.2%)
Other 1 (0.0%)

Patient Outcomes

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

Required Intervention 19,997 (99.6%)
62 (0.3%)
Other 4 (0.0%)
R 3 (0.0%)
S 2 (0.0%)
L 1 (0.0%)
Disability 1 (0.0%)
Hospitalization 1 (0.0%)
Life Threatening 1 (0.0%)

Yearly Trend

05
2005: 6
06
2006: 2
08
2008: 1
15
2015: 1
16
2016: 1
17
2017: 1
18
2018: 6
19
2019: 12,661
20
2020: 7,173
21
2021: 14
22
2022: 61
23
2023: 45
24
2024: 50
25
2025: 26
26
2026: 21