MAUDE report

MAUDE report 63017: BJORK SHILEY CONICAL DISC

Death · received Jan 13, 1997 · SHILEY INC

Key facts

MDR report key 63017
Report number 6000012-1997-00006
Event type Death
Brand name BJORK SHILEY CONICAL DISC
Model number 19ABP
Manufacturer SHILEY INC
Product code LWQ
Device class Class III
Date received by FDA Jan 13, 1997
Report date Dec 18, 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
  • 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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