MAUDE report

MAUDE report 16216: HOLLOW CORE SCREW

Injury · received Sep 16, 1994 · SYNTHES (USA)

Key facts

MDR report key 16216
Report number MW1003412
Event type Injury
Brand name HOLLOW CORE SCREW
Catalog number 48714, 49778
Manufacturer SYNTHES (USA)
Product code MCV
Device class Class III
Date received by FDA Sep 16, 1994
Report date Jul 7, 1994
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
  • 1–9 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:

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