PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received May 4, 2023 · Event occurred Apr 7, 2023
Report 3009189869-2023-00005 · MDR key 16869665
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
011022.03BCatalog number
011022.03B
Lot number
JI121538
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
54 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. THE SURGEON INDICATED THAT THE PATIENT WAS ARTHRITIC PRE-SURGERY AND THE CONDITION PROGRESSED POST-SURGERY. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUE RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE CAUSE OF THE EVENT WAS NOT DETERMINED TO BE RELATED TO THE DEVICE BASED ON THE INFORMATION AVAILABLE.
Description of Event or Problem
A TOTAL TALAR 4WEB CUSTOM-MADE DEVICE WAS EXPLANTED. IT WAS REPORTED TO THE MANUFACTURER THAT THE CARTILAGE PACK HAD DIMINISHED AND A REVISION SURGERY WAS PERFORMED TO REPLACE THE CAGE. THE SURGEON ALSO INDICATED THAT THE PATIENT WAS ARTHRITIC PRE-SURGERY, WHICH PROGRESSED POST-SURGERY LEADING TO CARTILAGE DEFICIENCY. REVISION SURGERY WAS COMPLETED SUCCESSFULLY.