PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Sep 22, 2020 · Event occurred Aug 20, 2020
Report 3009189869-2020-00012 · MDR key 10570600
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
101519.06DCatalog number
101519.06D
Lot number
61121191
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR
- 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 PERFORMED ON (B)(6) 2020. THE CUSTOM CAGE WAS EXPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED TO THE MANUFACTURER.