MAUDE report

MAUDE report 83617: ABUTMENT: SHOULDERED, 3MM INTERGRAL, 4.0

Injury · received Apr 15, 1997 · SULZER CALCITEK INC.

Key facts

MDR report key 83617
Report number 2023141-1997-00239
Event type Injury
Brand name ABUTMENT: SHOULDERED, 3MM INTERGRAL, 4.0
Catalog number 0711
Manufacturer SULZER CALCITEK INC.
Product code DZE
Device class Class II
Date received by FDA Apr 15, 1997
Report date Mar 17, 1997
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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