inforMED
MalfunctionHTT

UNKNOWN_INSTRUMENTSTIRE_PRODUCT

Received Aug 24, 2016 · Event occurred May 22, 2015

Report 0001811755-2016-01974 · MDR key 5901415

Device

Generic name

Unknown

Catalog number

UNK_ICO

Product problems

  • Break
  • Break

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT RETURNED FOR EVALUATION.

Description of Event or Problem

IT WAS REPORTED THAT A STANDARD BUR LONG CROSS CUT FISSURE BUR BROKE. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE QUALITY INVESTIGATION IS COMPLETE.

Description of Event or Problem

IT WAS REPORTED THAT A STANDARD BUR LONG CROSS CUT FISSURE BUR BROKE. NO FURTHER INFORMATION WAS PROVIDED.