RESPONSE SPINE 5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 40MM

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION AS IT IS STILL IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT HAS BEEN REPORTED THAT FOLLOWING A SPINAL DEFORMITY CORRECTION PROCEDURE, AN X-RAY TAKEN AT THE ONE YEAR FOLLOW-UP REVEALED A POSSIBLE FRACTURED PEDICLE SCREW. THE SCREW IS LOCATED AT THE LEFT PEDICLE AT THE T12 VERTEBRAE. THE PATIENT PRESENTED WITH BACK PAIN FOLLOWING A COLLISION IN PHYSICAL EDUCATION CLASS. BASED ON THE COMPUTERIZED TOMOGRAPHY SCANS AND PATIENT PAIN LEVELS, A REVISION PROCEDURE COULD BE PERFORMED AT A LATER DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.