K192394

Substantially Equivalent

Hi-Fatigue Bone Cement

Applicant: Osartis GmbH
Product code: LOD
Advisory panel: Orthopedic
Date received: 2019-09-03
Decision date: 2019-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dieburg, DE

Adverse events under product code LOD

product code LOD

Death: 44
Injury: 3,004
Malfunction: 895
Other: 4
Total: 3,947

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.