MAUDE report

MAUDE report 8629: PCA RESURFACING TIBIA

Injury · received Mar 18, 1994 · HOWMEDICA, INC.

Key facts

MDR report key 8629
Report number 33462-1994-01148
Event type Injury
Brand name PCA RESURFACING TIBIA
Catalog number UNKNOWN
Manufacturer HOWMEDICA, INC.
Product code HTG
Device class Class II
Date received by FDA Mar 18, 1994
Report date Feb 21, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 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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