FIREBIRD NXG POCT

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WENT TO A ROUTINE FOLLOW UP VISIT AFTER A DECOMPRESSION AND FUSION WITH THE USE OF FENESTERATED SCREWS THAT WERE IMPLANTED (B)(6) 2024. THE FOLLOW UP EXAM CONSISTED OF IMAGING THAT SHOWED SET SCREW BACKED OUT ON AN L2 -PELVIS JANUSUS FENESTRATED CASE. THE PATIENT REQUIRED A REVISION SURGERY THAT TOOK PLACE ON (B)(6)2025. NO SYMPTOMS WERE REPORTED BY PATIENT.

Additional Manufacturer Narrative

THE DEVICE DID NOT RETURNED FOR INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WENT TO A ROUTINE FOLLOW UP VISIT AFTER A DECOMPRESSION AND FUSION WITH THE USE OF FENESTERATED SCREWS THAT WERE IMPLANTED (B)(6) 2024. THE FOLLOW UP EXAM CONSISTED OF IMAGING THAT SHOWED SET SCREW BACKED OUT ON AN L2 -PELVIS JANUSUS FENESTRATED CASE. THE PATIENT REQUIRED A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2025. NO SYMPTOMS WERE REPORTED BY PATIENT.

Additional Manufacturer Narrative

THE SET SCREWS (PN: 36-2001 LN: UNK) WERE NOT RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE FIREBIRD NXG SET SCREWS BACKED OUT ON AN L2-PELVIS JANUS FENESTRATED CASE (LEGACY ORTHOFIX), AND WAS DISCOVERED DURING A ROUTINE FOLLOW UP EXAM WITH IMAGING. TWO RADIOGRAPHS WERE PROVIDED AND CONFIRMED 2 OF THE SET SCREWS HAD BACKED OUT FROM THE CONSTRUCT. IT SHOULD BE NOTED THAT THE PRIMARY SURGERY WAS PERFORMED USING 5.5X140MM MARINER MIS RODS (MM1-155140). THIS WAS AN OFF-LABEL USE - USAGE OF A LEGACY SEASPINE PRODUCT (MARINER MIS ROD) WITH AFOREMENTIONED LEGACY ORTHOFIX PRODUCTS. CEMENT WAS ALSO USED WITH THE FENESTRATED SCREWS, WHICH IS NOT INDICATED FOR USE IN THE US. THE REVISION SURGERY WAS PERFORMED USING 5.5X160MM ORTHOFIX STRAIGHT RODS (53-2160). THREE TORQUE HANDLES WERE RETURNED BY THE REP AND ONE OF THE HANDLES WAS FOUND TO BE SLIGHTLY UNDER SPEC. HOWEVER, IT IS NOT KNOWN WHICH OF THE THREE HANDLES WAS ACTUALLY USED IN THIS CASE. THE OFF-LABEL USE, SHORTER INITIAL ROD, AND THE TORQUE HANDLE BELOW SPEC COULD ALL BE CONTRIBUTING FACTORS TO THE POST-OP FAILURE OF THE CONSTRUCT. AN HHE (HHE-25-009) WAS INITIATED TO FURTHER EVALUATE THIS CASE AND ASSOCIATED RISKS. WITHOUT A LOT NUMBER, A REVIEW OF THE DHR AND NCMR DATABASE CANNOT BE COMPLETED.