NOBEL BIOCARE USA INC

Manufacturer adverse-event records for NOBEL BIOCARE 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 · 2019–2024 · heavy-book · quiet Death-code · injury-heavy

Volume signature

NOBEL BIOCARE USA INC sits in the heavy MAUDE book

NOBEL BIOCARE USA INC accounts for 122,529 FDA MAUDE reports (#26 of 443, heavy-book tercile). Death-coded event_type share is 0.00% (quiet); Injury share 96.4% (injury-heavy).

What the volume reading shows for NOBEL BIOCARE USA INC

The standout signal for NOBEL BIOCARE USA INC is filing volume: 122,529 adverse-event reports in FDA MAUDE (#26 of 443, heavy-book). Death-coded event_type share sits at 0.00% (quiet).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair NOBEL BIOCARE USA INC with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 1 device type, led in this extract by Injury at 118,111 (96.4% of event_type total). Peak single-year volume reaches 29,437 reports across 6 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

122,529
Total Reports
1
Event-type Death
118,111
Injury Reports
1
Device Types

Event Types

Injury 118,111 (96.4%)
Malfunction 4,417 (3.6%)
Death 1 (0.0%)

Patient Outcomes

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

Required Intervention 122,234 (99.9%)
R 96 (0.1%)
Hospitalization 5 (0.0%)
1 (0.0%)
S 1 (0.0%)
Death 1 (0.0%)

Devices (1)

Device Reports
Implant, Endosseous, Root-Form 122,529

Yearly Trend

19
2019: 168
20
2020: 16,702
21
2021: 28,431
22
2022: 27,858
23
2023: 29,437
24
2024: 19,933