Thoracolumbosacral Pedicle Screw System

Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System

Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.

SeaSpine Polyaxial Head

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:

Polyaxial screws do not meet performance standards.

Brand Name: PERLA TL MIS

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Brand Name: PERLA TL MIS

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Brand Name: Daytona Small Stature

Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

Brand Name: Daytona Small Stature

Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045

Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.

PERLA TL 25D SCREW REF:

Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tightened to torque but position askew

Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.

Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.