RAPHAEL
Received Feb 28, 2023 · Event occurred Feb 1, 2023
Report 3009051471-2023-00003 · MDR key 16456437
Device
Generic name
Pedicle Screw
Manufacturer
Ctl Medical CorporationProduct problems
- Material Separation
- Material Separation
Patient
68 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A HOUSING OF A POLYAXIAL PEDICLE SCREW SEPARATED FROM THE DISTAL SCREW BODY, THE EVENT, WE ONLY KNOW THAT HOUSING CAME OFF. IT CAN BE DEDUCED THAT THERE WAS A LARGE LATERAL BEND FORCE BEYOND PRESCRIBED RANGE ACTION INVOLVED AFTER THE SURGERY DATE OF (B)(6) 2023. SUCH LOAD COULD BE FROM THE TORSIONAL LOAD TRANSFER FROM THE OVERALL CONSTRUCT DUE TO PATIENT MOTION, FROM THE STORED ENERGY FROM THE CONSTRUCTED BUILDING, OR BOTH. FROM THE AVAILABLE INFORMATION, THE SOURCE OF PEELING LOAD THAT CAUSED THIS FAILURE IS INDETERMINATE. NO HARM NOR INJURY TO THE PATIENT WAS REPORTED. SURGEON HAS PLANNED REVISION FOR THIS INCIDENT.