InjuryHTN
EXTRA-THOR SUTR 2PK ST
Received Feb 12, 2026 · Event occurred Jan 15, 2026
Report 0001032347-2026-00040 · MDR key 24322577
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
25 YR · Male
- Bacterial Infection
- Pneumonia
Narrative
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.
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.