InjuryEZX
PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Apr 11, 2019 · Event occurred Aug 24, 2018
Report 3009189869-2019-00009 · MDR key 8504307
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
111117.07ACatalog number
111117.07A
Lot number
40206181
Product problems
- Break
- Break
Patient
64 YR
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN DUE TO THE IMPLANT FRACTURING WHICH LED TO REVISION.