UNKNOWN ORTHOPEDIATRICS RESPONSE PEDICLE SCREW

Additional Manufacturer Narrative

(B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

Description of Event or Problem

IT HAS BEEN REPORTED THAT FOLLOWING A SPINAL CORRECTION PROCEDURE, THE PATIENT WAS FOUND VIA RADIOGRAPH, TO HAVE A FRACTURED PEDICLE SCREW. A REVISION SURGERY HAS BEEN SCHEDULED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6: METHOD CODE(S): 4114 - 4109. H6: RESULT CODE(S): 3221. H6: CONCLUSION CODE(S): 4315. THE COMPLAINT WAS CONFIRMED THRU EVALUATION OF THE PROVIDED X-RAY. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.