CD HORIZON® GROWTH ROD CONVERSION SET

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS: PART # 7340000GR, LOT # UNKNOWN VISUAL AND OPTICAL INSPECTION CONFIRMED THE FEMALE HEX OF THE SCREWS HAS BEEN STRIPPED DUE TO TORSIONAL OVERLOAD. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR GROWING ROD EXTENSION TECHNIQUE. PROCEDURE OR THERAPY PERFORMED WAS EXTENSION SURGERY FOR THE GROWING ROD. IT WAS REPORTED THAT THE SET SCREW BROKE BEFORE THE BREAK-OFF. DURING GROWING ROD EXTENSION, THE DISTRACTOR CAME OFF AND INTERFERED WITH THE SET SCREW. IT IS BELIEVED THAT THE BREAKAGE WAS CAUSED BY THIS IMPACT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THIS SURGERY IS A REPEAT SURGERY. DEVICE HAS BEEN EXPLANTED-PARTIALLY. PRODUCT WAS IMPLANTED AND EXPLANTED ON THE SAME DAY, (B)(6) 2023. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT BODY, SO NO PLAN FOR ADDITIONAL SURGERY.