MAUDE report

MAUDE report 47548: SILTEX SPECTRUM POST-OP ADJUSTABLE

Injury · received Oct 1, 1996 · MENTOR H/S

Key facts

MDR report key 47548
Report number 1645337-1996-00029
Event type Injury
Brand name SILTEX SPECTRUM POST-OP ADJUSTABLE
Catalog number 354-2450M
Manufacturer MENTOR H/S
Product code LCJ
Device class Unclassified
Date received by FDA Oct 1, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • None Death reports for this brand
  • 10–99 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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