Failed Medical Device: Blackstone Medical, Inc. ICON Modular Spinal Fixation

Brief History Spinal Fusion – 1950’s Stress factors directed to this instrumentation by the human body turned out to be much greater than anticipated leading to a quest for structurally stronger instrumentation 1959 – First Screws 1970’s – First Screws and Rods 1983 – First Patent of this System

Brief History Continued System Challenges Nerve Compression Snapped Screws and Pedicles Too Rigid/Too Flexible Bone Grafting Issues Muscle Damage

Blackstone Medical, Inc. Products & Services Bone Screws Cervical Plate Spine Surgery Laparoscopic Discectomy System Cage Medical Devices Micro-discectomy System Spinal Fusion Discectomy Interbody Fusion Blackstone Medical Lumbar Spines Blackstone Blackstone Medical Inc. Disease Surgical Instruments Spinal Discitis Interbody Spinal Companies Implants Cervical Spine Bone Thoracic Spine Graft Lumbar Spine Lumbar Spinal Cord Spine Herniated Disc Orthopedic Surgery Degenerative Disc Back Stenosis Back Pain Disc Surgery Lower Back Pain Lumbar Discectomy Low Back Pain Desiccated Discs Degenerative Disc Disease Removing A Disc Bone Graft Disk Removal Instruments Titanium Implants Year Established 1996 Annual Sales US$10 Million - US$50 Million

Blackstone Medical, Inc. Screw and Rod Fixation Immobilize and Stabilize Spine Segments at Site of Surgery

ICON Modular Spinal Fixation “A surgical screw system for use with implantation rods includes a screw member, a receiver member, a pressure cap and a locking device. The screw member has a shaft and a head with a spherical undersurface and a conical tapered recess. The receiver member has an upper and lower portion, a u-shaped rod receiving channel and an axial bore. The u-shaped channel has two lateral legs at the upper portion and forms an opening leading to the axial bore. The axial bore near the lower portion includes an inwardly conical tapered surface which has a diameter larger than the shaft of the screw member but smaller than the head of the screw member. The conical surface forms a support upon which the spherical undersurface of the head of the screw member rests when the screw member is guided through the bore of the lower portion of the receiver member. The pressure cap is positioned within the axial bore and situated upon the head of the screw member. The locking device is designed for securing the rod within the u-shaped channel of the receiver member by applying a tightening torque upon the rod when positioned within the opening and the bore near the upper portion of the receiver member.”

Device Components Multi Shaft Screw Fixed Shaft Screw Bar Crosslinks Titanium Alloy

PRODUCT RECALLED! “The pedicle (vertebra stem) screws may separate from the screw heads, or from the rods that run between spinal segments. If this happens soon after the surgery, the spine may not fuse properly, and patients may need additional surgery to correct the problem. If not corrected, some patients may experience long-term pain and disability. The potential for injury depends on the specific condition being treated, and the degree of postoperative healing.”

Product availability ICON Modular Spinal Fixation System is no longer in use. Similar products are used by other companies.

Replacement or improvement? It seems to have been replaced by the SFS or Spinal Fixation System reduces the need for rod bending screws can bend with 42° range of motion. specialized thread minimizes the cross-threading of the screw

Improvements by the SFS 42° range of mobility Tapered head for a secure fit Threads are triangular in shape

Technological challenges Material rejection Staying in the bone Staying connected to the supporting rods

Company product testing Tension test on screw Testing of screw rod connection in multiple environments Dry Humid Wet Damp

Governmental regulations US Food and Drug Administration Maintain risk analysis of your device in the design validation Constant validation of company documentation and testing

Manufacturing issues establish and maintain Corrective and Preventive Action (CAPA) procedures designed to monitor the cause of the problems caused by the product

Safety issues Class I recall means that death or disability is a possibility Most serious of recalls issued by FDA Additional surgery possibility

Cost effective? Less material Product is useable

Reliability Use in lower thoracic and lumber region

Liability December 25, 2005 April 7, 2006 Blackstone Medical, Inc. informed the FDA of their intention to recall their product Notice to surgeons and distributors of the product warning them of the problem. Out of 484 surgeries, 4% were returned to surgery for the removal of the implant. April 7, 2006 FDA issued a Class I recall of the ICON Modular Spinal Fixation System. Consult with a lawyer if you had spinal surgery in 2005

There’s more. . . September 2006 Whistleblower lawsuit was filed from an employee, Susan Hutcheson Accused Blackstone Medical of giving kickbacks to surgeons and hospitals who used their implants Accused Blackstone Medical submitted false claims to Medicare and Medicaid Arkansas neurosurgeon, Patrick Chan, has admitted to receiving kickbacks Case is still on-going

Developments within the Field : Laparoscopic Surgery BMP – Bone Morphogenetic Protein Bioabsorbable Implants Polymers Mimic Characteristics of Bone