InjuryHRS
PURE PECTUS
Received Feb 27, 2026
Report 9610905-2026-00012 · MDR key 24469039
Device
Generic name
Connector Bar
Manufacturer
Kls Martin Se & Co. KgModel number
24-070-55-09Lot number
33597487
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PECTUS CONNECTOR BAR ASSEMBLY SCREW BECAME LOOSE APPROXIMATELY 18 MONTHS AFTER IMPLANTATION. IT WAS REMOVED AND REPLACED USING AN INDICATED KLS MARTIN PURE PECTUS SYSTEM TORQUE DRIVER TO SECURE THE ASSEMBLY SCREWS.