MAUDE report

MAUDE report 63664: RADIOPAQUE BONE CEMENT

Injury · received Jan 17, 1997 · HOWMEDICA PFIZER HOSP. PRODUCTS GROUP

Key facts

MDR report key 63664
Report number 63664
Event type Injury
Brand name RADIOPAQUE BONE CEMENT
Model number *
Catalog number 6191-1-001
Manufacturer HOWMEDICA PFIZER HOSP. PRODUCTS GROUP
Product code LOD
Device class Class II
Date received by FDA Jan 17, 1997
Report date Dec 24, 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
  • No 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