PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Dec 11, 2025
Report 3009189869-2025-00011 · MDR key 23783716
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
101223.12BCatalog number
101223.12B
Lot number
103338
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Description of Event or Problem
IT WAS REPORTED TO THE MANUFACTURER THAT THE EXISTING 4WEB CUSTOM-MADE DEVICE NEEDS TO BE REPLACED AS THE PATIENT HAD ANOTHER FRACTURE LEADING TO DETERIORATION OF THE DISTAL TIBIA. INITIAL SURGERY, PERFORMED ON (B)(6) 2023, WAS TO ADDRESS AN EXISTING TIBIAL SHAFT FRACTURE. THE 4WEB CUSTOM MADE DEVICE WILL BE REPLACED BY ANOTHER 4WEB CUSTOM MADE DEVICE. THE DATE OF REVISION 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 AS THE DEVICE REMAINS IMPLANTED. 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. A FOLLOW-UP REPORT WILL BE SUBMITTED AS MORE INFORMATION IS MADE AVAILABLE. THE ORIGINAL REPORT WAS SUBMITTED TO THE FDA ON 05-SEP-2025; HOWEVER, FDA REQUESTED 4WEB TO RESUBMIT AS THE INITIAL APPLICATION WAS ROUTED TO RADIOLOGICAL HEALTH INSTEAD OF HL7. THIS FILING IS A RE-SUBMISSION OF THE SAME REPORT. NO CHANGES HAVE BEEN MADE TO THE CONTENT PREVIOUSLY SUBMITTED.