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

2. 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

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

4. 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

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

6. 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.”

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

8. 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.”

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

10. 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

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

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

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

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

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

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

17. Cost effective?
Less material
Product is useable

18. Reliability
Use in lower thoracic and lumber region

19. 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

20. 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

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