REFORM TI CT MODULAR MIS PEDICLE SCREW SYSTEM

Additional Manufacturer Narrative

D4: LOT NUMBER - UNKNOWN. D4: PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER - FULL UDI NUMBER NOT AVAILABLE WITHOUT LOT IDENTIFICATION. H4: DEVICE MANUFACTURE DATE - UNKNOWN WITHOUT LOT IDENTIFICATION. H3: DEVICE EVALUATION - NO PRODUCT WAS RETURNED FOR EVALUATION. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, NO CONCLUSION CAN BE DRAWN REGARDING THE DISASSEMBLY REPORTED. IT WAS NOTED THAT THE TULIP WAS SUCCESSFULLY REATTACHED TO THE SCREW TO COMPLETE THE PROCEDURE. REVIEW OF DEVICE HISTORY RECORDS AND LOT SPECIFIC COMPLAINT HISTORY REVIEW WERE NOT POSSIBLE. TWO-YEAR COMPLAINT HISTORY REVIEW DID NOT REVEAL A TREND FOR REPORTS OF THIS NATURE FOR THIS PART NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2026, IN AUSTRALIA, UTILIZING THE REFORM CT PEDICLE SCREW SYSTEM. THE MODULAR POLYAXIAL TULIP ASSEMBLY REFORM MIS PEDICLE SCREW SYSTEM (64-MT-0403) WAS ASSEMBLED ON A 5-BP-XXXX SERIES SCREW BY THE NURSE AND CHECKED THAT IT WAS SECURE. THE SCREW WAS THEN ASSEMBLED ONTO A NAVIGATED/ASSEMBLED SCREWDRIVER. THE SURGEON PLACED THE SCREW IN THE PEDICLE AND UPON REMOVING THE SCREWDRIVER, THE TULIP FELL OFF AND INTO THE SURGICAL SITE. IT WAS RECOVERED AND REASSEMBLED, WITH A BIT OF DIFFICULTY, TO COMPLETE THE PROCEDURE.