Thoracolumbosacral pedicle screw system

Description of Event or Problem

WE RECEIVED A COMPLAINT FROM THE US ON (B)(6) 2026 (RESGISTERED UNDER (B)(4) REPORTING THAT DURING PATIENT'S FOLLOW UP VISIT, X-RAYS PICTURES SHOWS THE SCREW HANK IS BROKEN. NO OTHER INFORMATION AVAILABLE (NO DATE, NO REFERENCE, NO LOT NUMBER, NO HEALTH IMPACT REPORTED). PENDING ADITIONNAL INFORMATION. LATE SUBMISSION : THE REPORTABILITY ASSESSMENT FOR CASE (B)(4) WAS PERFORMED USING THE APPLICABLE DECISION TREE. HOWEVER, THE OUTCOME OF THE ASSESSMENT WAS INCORRECT, AS THE EVENT MEETS THE REPORTABILITY CRITERIA AND SHOULD HAVE BEEN CONSIDERED REPORTABLE. CONSEQUENTLY, THE CASE WAS NOT REPORTED WITHIN THE REQUIRED REGULATORY TIMELINES. THIS ISSUE HAS BEEN ADDRESSED UNDER SYSTEMNC-2026-0107.