CONTOURED DEFORMITY ROD, DUAL HEX; SIZE Ø5.5X375 MM COCR
Received Apr 2, 2025 · Event occurred Mar 11, 2025
Report 3004774118-2025-00053 · MDR key 21758948
Device
Generic name
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Manufacturer
K2m, Inc.Catalog number
111-B655375
Lot number
UNKNOWN
Product problems
- Fracture
- Fracture
Patient
71 YR · Male
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY 3.5 MONTHS POST-OPERATIVELY TO ADDRESS TWO FRACTURED DENALI CONTOURED DEFORMITY RODS. THIS REPORT CAPTURES THE FIRST OF TWO RODS.
Description of Event or Problem
AN UPDATED COMMUNICATION RECEIVED FROM THE FIELD INDICATES THAT ONLY ONE DENALI CONTOURED DEFORMITY ROD FRACTURED. THIS REPORT CAPTURES THE FRACTURED ROD.
Additional Manufacturer Narrative
ADDITIONAL DATA: A2, A3A CORRECTED DATA: B5 H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION.