MAUDE report

MAUDE report 42376: ABUTMENT DIRECT, GOLD COPING, 3.25

Injury · received Oct 16, 1996 · CALCITEK

Key facts

MDR report key 42376
Report number 2023141-1996-00144
Event type Injury
Brand name ABUTMENT DIRECT, GOLD COPING, 3.25
Catalog number 0602
Manufacturer CALCITEK
Product code DZE
Device class Class II
Date received by FDA Oct 16, 1996
Report date Sep 17, 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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