MAUDE report

MAUDE report 9488: ANDREWS SPINAL SURGICAL TABLE

No Answer Provided · received Aug 29, 1994 · ORTHOPEDIC SYSTEMS, INC.

Key facts

MDR report key 9488
Report number 9488
Event type No Answer Provided
Brand name ANDREWS SPINAL SURGICAL TABLE
Model number 5800-SST 3000
Manufacturer ORTHOPEDIC SYSTEMS, INC.
Product code JEA
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Aug 29, 1994
Report date Jul 27, 1994
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
  • 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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