PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Aug 5, 2021 · Event occurred Jul 9, 2021
Report 3009189869-2021-00004 · MDR key 12281783
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
081120.08ACatalog number
081120.08A
Lot number
JI13979
Product problems
- Break
- Break
Patient
65 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. THE SURGEON REPORTED AN INCIDENTAL FINDING OF THE IMPLANT BEING FRACTURED. NO REVISION OR EXPLANTATION HAS BEEN SCHEDULED AS OF THE DATE OF THIS REPORT. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION SINCE IT REMAINS IMPLANTED IN THE PATIENT.
Description of Event or Problem
IT WAS REPORTED TO THE MANUFACTURER THAT A CUSTOM IMPLANT BROKE IN THE PATIENT. THE BROKEN IMPLANT WAS FOUND DURING POST OPERATIVE CHECK UP. NO REVISION SURGERY OR EXPLANTATION HAS BEEN SCHEDULED AS OF THE DATE OF THIS REPORT. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020. NO OTHER COMPLICATIONS WERE REPORTED TO THE MANUFACTURER.