MAUDE report

MAUDE report 32664: OMNIFIT PSL MICROSTRUCTURED ACCETABULAR SHELL

Injury · received Nov 18, 1994 · OSTEONICS CORP.

Key facts

MDR report key 32664
Report number 33237-1994-09001
Event type Injury
Brand name OMNIFIT PSL MICROSTRUCTURED ACCETABULAR SHELL
Catalog number 2017-0052
Manufacturer OSTEONICS CORP.
Product code KWB
Device class Class III
Date received by FDA Nov 18, 1994
Report date Nov 18, 1994
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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