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 IN AUSTRALIA ON (B)(6) 2026, UTILIZING THE REFORM TI MODULAR SYSTEM, 59-BP-XXXX SERIES SCREWS WITH THE REFORM TI MODULAR POLYAXIAL TULIP ASSEMBLY (39-MT-0401). THE TULIP AND THE SHANK WERE SECURELY ASSEMBLED BY THE NURSE AND CHECKED THAT THEY WERE SECURE. SCREW WAS ASSEMBLED ONTO A NAVIGATED/ASSEMBLED SCREWDRIVER. 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 RE-ASSEMBLED ONTO THE SHANK IN-SITU. THE REST OF THE SURGERY PROCEEDED AS PLANNED.