MAUDE report

MAUDE report 74711: BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE

Death · received Mar 7, 1997 · SHILEY INC.

Key facts

MDR report key 74711
Report number 6000012-1997-00011
Event type Death
Brand name BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE
Model number 29ABC
Manufacturer SHILEY INC.
Product code LWQ
Device class Class III
Date received by FDA Mar 7, 1997
Report date Feb 19, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 100–999 MAUDE reports for this brand
  • 10–99 Death reports for this brand
  • 100–999 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:

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