MAUDE report

MAUDE report 10524: TRANSPEDICULAR BONE SCREW SYSTEM

No Answer Provided · received Nov 1, 1993 · DANEK GROUP, INC.

Key facts

MDR report key 10524
Report number MW4000049
Event type No Answer Provided
Brand name TRANSPEDICULAR BONE SCREW SYSTEM
Manufacturer DANEK GROUP, INC.
Product code KWP
Device class Class II
Date received by FDA Nov 1, 1993
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
  • None Injury reports for this brand
  • No Adverse event flagged
  • Yes 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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