MAUDE report

MAUDE report 69461: BIPOLAR COCR 26MM/44MM

Injury · received Feb 19, 1997 · SULZER ORTHOPEDICS, INC.

Key facts

MDR report key 69461
Report number 2935620-1997-00005
Event type Injury
Brand name BIPOLAR COCR 26MM/44MM
Catalog number 404-26-044C
Manufacturer SULZER ORTHOPEDICS, INC.
Product code KWB
Device class Class III
Date received by FDA Feb 19, 1997
Report date Feb 17, 1997
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
  • None Death reports for this brand
  • 1–9 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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