PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Mar 8, 2023 · Event occurred Feb 7, 2023
Report 3009189869-2023-00001 · MDR key 16505853
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
060122.01ACatalog number
060122.01A
Lot number
101281
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
78 YR · Male
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. SURGEON INDICATED THAT HE OBSERVED AN INFECTION AND THAT THE CAGE WAS SUBSEQUENTLY EXPLANTED. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO PRODUCT WAS RETURNED FOR EVALUATION.
Description of Event or Problem
DURING POST-OPERATIVE CHECK-UPS BY THE SURGEON, HE OBSERVED AN INFECTION. THE ORIGINAL SURGERY WAS PERFOMED ON (B)(6) 2022. THE CUSTOM CAGE WAS EXPLANTED ON (B)(6) 2023. NO FURTHER COMPLICATIONS WERE REPORTED TO THE MANUFACTURER.