PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Feb 26, 2024 · Event occurred Jan 31, 2024
Report 3009189869-2024-00004 · MDR key 18783923
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
070517.03BCatalog number
070517.03B
Lot number
40725171
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
51 YR · Male
- 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. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. NO RADIOGRAPHS WERE PROVIDED. THE SURGEON INDICATED THAT THE PATIENT HAD POOR BONE QUALITY. THE PRODUCTION RECORDS WERE REVIEWED FOR THE PRODUCT INVOLVED. NO MANUFACTURING DEFICIENCES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
A 4WEB CUSTOM-MADE DEVICE WAS EXPLANTED. THE INITIAL SURGERY WAS PERFORMED IN (B)(6) 2017. IT WAS REPORTED TO THE MANUFACTURER THAT THE PATIENT DID NOT HEAL. IT WAS ALSO REPORTED THAT THE PATIENT HAD A FALL BUT NO MECHANICAL FAILURE OF 4WEB DEVICE WAS NOTED. THE REVISION SURGERY WAS PERFORMED TO ACCOMPLISH ANKLE ARTHRODESIS. REVISION SURGERY WAS COMPLETED USING ANOTHER 4WEB CUSTOM-MADE DEVICE.