MAUDE report

MAUDE report 54500: GROSSE & KEMPF TIBIAL LOCKING NAIL

Malfunction · received Dec 2, 1996 · HOWMEDICA, INC.

Key facts

MDR report key 54500
Report number 9610622-1996-00029
Event type Malfunction
Brand name GROSSE & KEMPF TIBIAL LOCKING NAIL
Catalog number 3518-2-315
Manufacturer HOWMEDICA, INC.
Product code HSB
Device class Class II
Date received by FDA Dec 2, 1996
Report date Dec 2, 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
  • 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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