PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Mar 26, 2026 · Event occurred Sep 5, 2025
Report 3009189869-2026-00006 · MDR key 24701504
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
080124.01ACatalog number
080124.01A
Lot number
104723
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR · Male
- Laceration(s)
- Neuropathy
Narrative
Description of Event or Problem
IT WAS REPORTED TO 4WEB MEDICAL THAT A REVISION SURGERY WAS PERFORMED AS THE PATIENT'S SKIN SPLIT OPEN WHILE WALKING. THE PATIENT WAS NOTED TO HAVE NEUROPATHY WITH ASSOCIATED FOOT NUMBNESS. THE CUSTOM 4WEB DEVICE WAS EXPLANTED APPROXIMATELY 10 MONTHS FOLLOWING THE INITIAL IMPLANTATION PROCEDURE. A SUBSEQUENT PROCEDURE IS PLANNED TO IMPLANT A NEW CUSTOM 4WEB DEVICE AT THE SAME ANATOMICAL LOCATION; HOWEVER, THE REVISION SURGERY HAS NOT YET BEEN SCHEDULED.
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. THE PRODUCTION RECORDS WERE REVIEWED FOR THE PRODUCT INVOLVED, NO MANUFACTURING DEFICIENCIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT.