InjuryHTN
EXTRA-THOR SUTR 2PK ST
Received Feb 12, 2026 · Event occurred Jan 15, 2026
Report 0001032347-2026-00045 · MDR key 24322593
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
25 YR · Male
- Bacterial Infection
- Pneumonia
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL PROCEDURE AND WAS REVISED APPROXIMATELY 14 DAYS POST-IMPLANTATION DUE TO MRSA PNEUMONIA INFECTION. ALL COMPONENTS WERE REMOVED AND TWO WASHERS REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.