MAUDE report

MAUDE report 49863: BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE

Death · received Nov 14, 1996 · SHILEY INCORPORATED

Key facts

MDR report key 49863
Report number 6000012-1996-00009
Event type Death
Brand name BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE
Model number 31MBRC
Manufacturer SHILEY INCORPORATED
Product code LWQ
Device class Class III
Date received by FDA Nov 14, 1996
Report date Nov 14, 1996
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
  • 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:

Browse all MAUDE medical device reports