COCHLEAR BONE ANCHORED SOLUTIONS AB

Manufacturer adverse-event records for COCHLEAR BONE ANCHORED SOLUTIONS 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 · 2008–2026 · mid-book · quiet Death-code · injury-heavy

Injury-mix signature

COCHLEAR BONE ANCHORED SOLUTIONS AB leans injury-heavy in event_type mix

Injury-coded event_type share is 99.6% (injury-heavy tercile) beside 0.02% Death-coded (quiet). Volume band: mid.

What the Injury-mix reading shows for COCHLEAR BONE ANCHORED SOLUTIONS AB

The standout signal for COCHLEAR BONE ANCHORED SOLUTIONS AB is Injury-mix: 99.6% Injury-coded (injury-heavy) beside 0.02% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for COCHLEAR BONE ANCHORED SOLUTIONS AB. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 8 device types, led in this extract by Injury at 12,616 (99.6% of event_type total). Peak single-year volume reaches 1,220 reports across 18 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

12,668
Total Reports
2
Event-type Death
12,616
Injury Reports
8
Device Types

Event Types

Injury 12,616 (99.6%)
Malfunction 36 (0.3%)
14 (0.1%)
Death 2 (0.0%)

Patient Outcomes

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

Required Intervention 12,432 (97.0%)
R 143 (1.1%)
Hospitalization 116 (0.9%)
Other 58 (0.5%)
H 26 (0.2%)
22 (0.2%)
O 8 (0.1%)
L 4 (0.0%)
Life Threatening 4 (0.0%)
Death 2 (0.0%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Yearly Trend

08
2008: 4
10
2010: 15
11
2011: 66
12
2012: 313
13
2013: 614
14
2014: 540
15
2015: 814
16
2016: 889
17
2017: 841
18
2018: 869
19
2019: 1,067
20
2020: 1,220
21
2021: 1,174
22
2022: 1,083
23
2023: 1,126
24
2024: 810
25
2025: 793
26
2026: 430