MAUDE report

MAUDE report 60712: OSTEONICS OMNIFIT 10 DEGREE CUP INSERT

Injury · received Jan 2, 1997 · OSTEONICS CORP.

Key facts

MDR report key 60712
Report number 2243265-1996-00045
Event type Injury
Brand name OSTEONICS OMNIFIT 10 DEGREE CUP INSERT
Catalog number 2043-2246
Manufacturer OSTEONICS CORP.
Product code LWJ
Device class Class II
Date received by FDA Jan 2, 1997
Report date Dec 30, 1996
Report source Maude

At a glance

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