MAUDE report

MAUDE report 77239: TI 250 DIA HEX-HEAD ROD, L=20CM

Injury · received Mar 19, 1997 · SOFAMOR DANEK MFG

Key facts

MDR report key 77239
Report number 1030489-1997-00007
Event type Injury
Brand name TI 250 DIA HEX-HEAD ROD, L=20CM
Catalog number X0394-720
Manufacturer SOFAMOR DANEK MFG
Product code KWP
Device class Class II
Date received by FDA Mar 19, 1997
Report date Mar 19, 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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