MAUDE report

MAUDE report 42694: ABUTMENT: SHOULDRED, 5MM,INTEGRAL,4.0

Injury · received Oct 11, 1996 · CALCITEK

Key facts

MDR report key 42694
Report number 2023141-1996-00122
Event type Injury
Brand name ABUTMENT: SHOULDRED, 5MM,INTEGRAL,4.0
Catalog number 0713
Manufacturer CALCITEK
Product code DZE
Device class Class II
Date received by FDA Oct 11, 1996
Report date Sep 12, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 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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