InjuryJDQ
SDB CERCLAGE SYSTEM
Received Apr 17, 2025 · Event occurred Mar 17, 2025
Report 1833824-2025-42890 · MDR key 21859236
Device
Generic name
Cerclage, Fixation
Manufacturer
Pioneer Surgical Technology, Inc.Model number
611.105.01S-USProduct problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED TO RESOLVE THAT ON (B)(6) 2025 A PATIENT UNDERWENT A PRIMARY SURGERY WITH THE SYNTHES ORTHOPEDIC CABLE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, A REVISION SURGERY WAS PERFORMED TO CORRECT MISALIGNMENT. DURING THE PRIMARY SURGERY, THE CABLE WAS USED TO REDUCE THE FRACTURED DIAPHYSIS, HOWEVER THE DISTAL BONE FRAGMENT WAS FIXED WITH EXCESSIVE INTERNAL ROTATION, WHICH MADE REHABILITATION DIFFICULT.