MAUDE report

MAUDE report 41901: TSRH PEDICLE SCREW

Injury · received Oct 9, 1996 · DANEK GROUP, INC.

Key facts

MDR report key 41901
Report number MW1010038
Event type Injury
Brand name TSRH PEDICLE SCREW
Model number *
Catalog number *
Manufacturer DANEK GROUP, INC.
Product code MCV
Device class Class III
Date received by FDA Oct 9, 1996
Report date Sep 25, 1996
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:

Browse all MAUDE medical device reports