MAUDE report

MAUDE report 24949: TSRH SPINAL FUSION SYSTEM

No Answer Provided · received Aug 25, 1995 · SOFAMOR DANEK MED

Key facts

MDR report key 24949
Report number MW4000688
Event type No Answer Provided
Brand name TSRH SPINAL FUSION SYSTEM
Model number UNKNOWN
Catalog number UNKNOWN
Manufacturer SOFAMOR DANEK MED
Product code JDN
Device class Class II
Date received by FDA Aug 25, 1995
Report date May 1, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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:

Browse all MAUDE medical device reports