MAUDE report

MAUDE report 34173: SAFHS SONIC ACCELERATED FRACTURE HEALING SYSTEM

No Answer Provided · received Apr 15, 1996 · EXOGEN, INC.

Key facts

MDR report key 34173
Report number MW5000017
Event type No Answer Provided
Brand name SAFHS SONIC ACCELERATED FRACTURE HEALING SYSTEM
Manufacturer EXOGEN, INC.
Product code LPQ
Device class Class II
Date received by FDA Apr 15, 1996
Report date Apr 12, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 10–99 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 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:

Browse all MAUDE medical device reports