PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Feb 24, 2026 · Event occurred Jan 20, 2026
Report 3009189869-2026-00001 · MDR key 24438576
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
093024.22BCatalog number
093024.22B
Lot number
105082
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR · Male
- Medical device site infection
Narrative
Description of Event or Problem
IT WAS REPORTED TO THE MANUFACTURER THAT 4WEB CUSTOM-MADE DEVICE WAS EXPLANTED A YEAR AFTER INITIAL SURGERY. IT WAS INFORMED THAT THE PATIENT HAD ACTIVE INFECTION DURING THE INTIAL SURGERY PERFORMED ON (B)(6) 2024. THE 4WEB DEVICE WAS EXPLANTED ON (B)(6) 2026 DUE TO INFECTION AND WAS REPLACED BY AN ANTI-BIOTIC SPACER. THE PATIENT WILL UNDERGO ANOTHER SURGERY TO REPLACE THE SPACER WITH A 4WEB CUSTOM MADE DEVICE.THE DATE OF SURGERY HAS NOT BEEN FINALIZED YET.
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 DEFICIENCES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.