PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Jun 29, 2026
Report 3009189869-2026-00011 · MDR key 25653570
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
032524.13BCatalog number
032524.13B
Lot number
103941
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
77 YR · Male
- Medical device site infection
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. 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 CONTRIBUTED TO THE INCIDENT.
Description of Event or Problem
4WEB RECEIVED A REQUEST FOR A PATIENT WHO HAD ALREADY RECEIVED A 4WEB CUSTOM DEVICE IN THEIR LEFT FOOT. THE NEW REQUEST FOR CUSTOM DEVICE WAS FOR THE PATIENT'S RIGHT FOOT. UPON FURTHER INQUIRY, 4WEB WAS INFORMED THAT THE PATIENT HAD UNDERGONE BELOW-THE-KNEE AMPUTATION OF THE LEFT FOOT FEW YEARS AGO DUE TO AN INFECTION. THE DATE OF AMPUTATION IS UNKNOWN.