MAUDE report

MAUDE report 31366: RADIOPAQUE BONE CEMENT

Injury · received Mar 20, 1996 · HOWMEDICA, INC.

Key facts

MDR report key 31366
Report number MW4001103
Event type Injury
Brand name RADIOPAQUE BONE CEMENT
Catalog number 6191-1-001
Manufacturer HOWMEDICA, INC.
Product code LOD
Device class Class II
Date received by FDA Mar 20, 1996
Report date Jan 29, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes Adverse event flagged
  • Yes Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

Browse all MAUDE medical device reports