PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Apr 5, 2023 · Event occurred Mar 7, 2023
Report 3009189869-2023-00002 · MDR key 16686479
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
030620.02ACatalog number
030620.02A
Lot number
J191724
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
54 YR · Female
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. SURGEON INDICATED THAT THE CAGE HAD SUBSIDED AND DID NOT BELIEVE THAT THE IMPLANT FAILURE WAS RELATED TO THE DESIGN OF THE 4WEB IMPLANT. THE PATIENT WAS REPORTED TO HAVE COMORBIDITIES. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. A VISUAL INSPECTION OF THE EXPLANTED CAGE WAS PERFORMED. THE IMPLANT FEATURES REMAINED INTACT.
Description of Event or Problem
APPROXIMATELY TWO AND HALF YEARS AFTER THE ORIGINAL SURGERY, THE PATIENT REPORTED PAIN. THE SURGEON INDICATED THAT THE IMPLANT SUBSIDED. DURING THE REVISION SURGERY, THE EXISTING CAGE WAS EXPLANTED AND A NEW CUSTOM-DEVICE WAS IMPLANTED. THE SURGEON ALSO INDICATED THAT THE IMPLANT WAS NOT THE CAUSE OF THE SUBSIDENCE.