PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Aug 26, 2024
Report 3009189869-2024-00013 · MDR key 20065689
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
111620.07BCatalog number
111620.07B
Lot number
JI103747
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Arthritis
- Arthritis
Narrative
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THE CASE FILE RECORDS WERE REVIEWED, NO MANUFACTURING DEVIATIONS WERE NOTED. BASED ON THE INFORMATION AVAILABLE AT THE POINT, IT IS UNCLEAR IF THE EVENT IS LINKED TO 4WEB DEVICE. IF MORE INFORMATION IS MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. IT WAS REPORTED THAT CALCANEAL SUSTENTACULUM TALI FRACTURED DURING THE INITIAL SURGERY WHICH TOOK PLACE ON (B)(6) 2021. ABOUT TWO AND HALF YEARS POST INITIAL SURGERY, IT WAS REPORTED TO THE MANUFACTURER THAT PATIENT'S RIGHT LEG, BELOW-THE-KNEE, WAS AMPUTATED.