4WEB MEDICAL
Received Feb 7, 2022 · Event occurred Jan 7, 2022
Report 3009189869-2022-00003 · MDR key 13471798
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
110521.03ACatalog number
110521.03A
Lot number
JI23130
Product problems
- Break
- Break
Patient
43 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. THE SURGEON DETERMINED THAT THE IMPLANT STRUCTURE WAS INTACT AND DECIDED TO COMPLETE THE SURGERY. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING AND/OR DESIGN THAT MAY HAVE CONTRIBUTED TO THE EVENT. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION SINCE IT REMAINS IMPLANTED IN THE PATIENT. A SUPPLEMENTAL REPORT WILL BE FILED AS NEW INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED TO THE MANUFACTURER THAT THE THREADED PORTION OF THE CUSTOM IMPLANT BROKE WHILE THE SURGEON ATTEMPTED TO USE THE IMPLANT INSERTER AS A LEVER ARM TO TURN THE IMPLANT IN THE DEFECT AREA. THE INSERTION FEATURE BROKE FREE OF THE IMPLANT. THE SURGEON DETERMINED THAT THE STRUCTURE OF THE IMPLANT WAS INTACT AND PROCEEDED TO COMPLETE THE SURGERY WITH THE SAME IMPLANT. NO OTHER COMPLICATIONS WERE REPORTED TO THE MANUFACTURER.
Additional Manufacturer Narrative
THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. THE SURGEON DETERMINED THAT THE IMPLANT STRUCTURE WAS INTACT AND DECIDED TO COMPLETE THE SURGERY. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING AND/OR DESIGN THAT MAY HAVE CONTRIBUTED TO THE EVENT. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION SINCE IT REMAINS IMPLANTED IN THE PATIENT. A SUPPLEMENTAL REPORT WILL BE FILED AS NEW INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED TO THE MANUFACTURER THAT THE THREADED PORTION OF THE CUSTOM IMPLANT BROKE WHILE THE SURGEON ATTEMPTED TO USE THE IMPLANT INSERTER AS A LEVER ARM TO TURN THE IMPLANT IN THE DEFECT AREA. THE INSERTION FEATURE BROKE FREE OF THE IMPLANT. THE SURGEON DETERMINED THAT THE STRUCTURE OF THE IMPLANT WAS INTACT AND PROCEEDED TO COMPLETE THE SURGERY WITH THE SAME IMPLANT. NO OTHER COMPLICATIONS WERE REPORTED TO THE MANUFACTURER.