NOBEL BIOCARE AB

Manufacturer adverse-event records for NOBEL BIOCARE AB 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 · 1996–2025 · heavy-book · quiet Death-code · injury-heavy

Volume signature

NOBEL BIOCARE AB sits in the heavy MAUDE book

NOBEL BIOCARE AB accounts for 883,337 FDA MAUDE reports (#6 of 443, heavy-book tercile). Death-coded event_type share is 0.00% (quiet); Injury share 99.0% (injury-heavy).

What the volume reading shows for NOBEL BIOCARE AB

The standout signal for NOBEL BIOCARE AB is filing volume: 883,337 adverse-event reports in FDA MAUDE (#6 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 AB 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 11 device types, led in this extract by Injury at 874,265 (99.0% of event_type total). Peak single-year volume reaches 202,966 reports across 16 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

883,337
Total Reports
22
Event-type Death
874,265
Injury Reports
11
Device Types

Event Types

Injury 874,265 (99.0%)
Malfunction 9,026 (1.0%)
Death 22 (0.0%)
Other 17 (0.0%)
7 (0.0%)

Patient Outcomes

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

Required Intervention 881,666 (99.9%)
R 652 (0.1%)
51 (0.0%)
Death 34 (0.0%)
Other 27 (0.0%)
Hospitalization 14 (0.0%)
O 8 (0.0%)
Life Threatening 7 (0.0%)
D 4 (0.0%)
H 3 (0.0%)
Congenital Anomaly 3 (0.0%)
S 2 (0.0%)

Yearly Trend

96
1996: 1,010
97
1997: 2,161
00
2000: 5
01
2001: 4
04
2004: 3
05
2005: 23
06
2006: 14
14
2014: 2
18
2018: 3
19
2019: 48,594
20
2020: 97,006
21
2021: 160,748
22
2022: 187,319
23
2023: 202,966
24
2024: 183,456
25
2025: 23