MAUDE report

MAUDE report 12112: SURGICAL SIMPLEX BONE CEMENT

Death · received Mar 18, 1994 · HOWMEDICAL, INC.

Key facts

MDR report key 12112
Report number MW1001146
Event type Death
Brand name SURGICAL SIMPLEX BONE CEMENT
Catalog number 6191-1-001
Manufacturer HOWMEDICAL, INC.
Product code LOD
Device class Class II
Date received by FDA Mar 18, 1994
Report date Mar 1, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • None Injury reports for this brand
  • Yes Adverse event flagged
  • No 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:

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