PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Dec 10, 2024 · Event occurred Nov 8, 2024
Report 3009189869-2024-00019 · MDR key 20896756
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
040424.03(B)Catalog number
040424.03(B)
Lot number
104125
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED TO THE MANUFACTURER THAT THE PATIENT WALKED AGAINST SURGEON'S POST-OPERATIVE CARE INSTRUCTIONS CAUSING NAIL TO DISPLACE, POTENTIALLY FRACTURING THE CALCANEAL BONE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REPLACE THE EXISTING 4WEB CUSTOM IMPLANT WITH ANOTHER 4WEB CUSTOM-MADE DEVICE. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2024.
Additional Manufacturer Narrative
THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. REVIEW OF THE 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 WAS REPORTED TO BE BIOLOGICALLY CONTAMINATED. REVISION SURGERY WAS PERFORMED SUCCESSFULLY TO REPLACE THE DEVICE WITH ANOTHER 4WEB CUSTOM CAGE.