InjuryJDQ
STERNAL CABLE SYSTEM
Received Jan 10, 2025 · Event occurred Nov 15, 2024
Report 1833824-2025-42411 · MDR key 21129505
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Implant Pain
- Implant Pain
Narrative
Description of Event or Problem
IT WAS REPORTED TO RESOLVE ON (B)(6) 2024 THAT A PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE STERNAL CABLE SYSTEM WITH STERNALOCKBLU PLATES. THE PATIENT MENTIONED PAIN AT THE INCISION SITE AND A CT SCAN REVEALED THAT NON-UNION HAD OCCURRED. THERE WAS NO EVIDENCE OF MECHANICAL HARDWARE FAILURE.