MAUDE report

MAUDE report 56940: OSTEONICS OMNIFIT 10 DEGREE CUP INSERT -SERIES I

Injury · received Dec 13, 1996 · OSTEONICS CORP.

Key facts

MDR report key 56940
Report number 2243265-1996-00042
Event type Injury
Brand name OSTEONICS OMNIFIT 10 DEGREE CUP INSERT -SERIES I
Catalog number 2001-3254
Manufacturer OSTEONICS CORP.
Product code KWB
Device class Class III
Date received by FDA Dec 13, 1996
Report date Dec 10, 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
  • 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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