inforMED
InjuryKWD

CARTIVA

Received May 28, 2019 · Event occurred Jul 3, 2018

Report MW5086956 · MDR key 8650607

Device

Generic name

Prosthesis, Toe, Hemi, Phalangeal

Manufacturer

Cartiva, Inc.

Product problems

  • Break

Patient

76 YR

  • No Code Available
  • No Code Available

Narrative

Description of Event or Problem

REVISION OF APPROVED IMPLANT THAT WAS SIGNIFICANTLY DAMAGED AND HAD DECREASED IN SIZE SINCE INITIAL IMPLANTATION. FDA SAFETY REPORT ID # (B)(4).