DeviceClearance

K232265

Substantially Equivalent

BLUEPRINT™ Patient Specific Instrumentation

Applicant
Tornier S.A.S.
Product code
PHX
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Montbonnot-Saint-Martin, FR
Download summary PDF View on FDA.gov ↗

Adverse events under product code PHX

product code PHX
Death
10
Injury
9,705
Malfunction
1,252
Total
10,967

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.