PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT
Received Jun 10, 2020
Report 3009189869-2020-00004 · MDR key 10138881
Device
Generic name
Physician Designed Custom Orthopedic Implant
Manufacturer
4web, Inc.Model number
021719.06BCatalog number
021719.06B
Lot number
40411191
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
51 YR
- Swelling
- Swelling
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 A REVISION SURGERY WAS REQUIRED, WHICH WAS PERFORMED IN (B)(6) 2020. THE EXACT DATE OF THE REVISION SURGERY IS UNAVAILABLE AT THIS TIME. THERE WAS NO INFORMATION AVAILABLE ON WHETHER THE PATIENT WAS COMPLIANT WITH POST-OPERATIVE INSTRUCTIONS. 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
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RED SWOLLEN ANKLE. DURING ADDITIONAL FOLLOW-UP SESSIONS, THE SURGEON SUSPECTED SCREW FAILURE. A REVISION SURGERY WAS PERFORMED WHERE THE SURGEON OBSERVED A LACK OF FUSION WITH THE IMPLANT. THE IMPLANT AND THE SCREW WERE EXPLANTED. NO COMPLICATIONS WERE REPORTED TO THE MANUFACTURER.