Excella MIS System Post Market Surveillance Protocol

Location and Physician

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* 1. Hospital Name

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* 2. Address

Address

Address 2

City/Town

State/Province

ZIP/Postal Code

Phone Number

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* 3. Physician Name

Patient Demographics

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* 4. Patient Gender

Male

Female

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* 5. Patient Age

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* 6. Patient Weight

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* 7. Patient Height

Procedure

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* 8. Surgery for this level

First

Second

Third

Fourth

Other (please specify)

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* 9. Fusion Procedure

TLIF

PLIF

ALIF

XLIF

Other (please specify)

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* 10. Screw Placement Technique

Wiltse Approach (Trans-fascial)

Percuitaneous Approach (Sub-fascial thru stab incisions)

Other (please specify)

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* 11. Operation Date and Time

Date / Time

Date

Time

AM/PM

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* 12. Total Operative Time (00:00)

Implants used

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* 13. Screw Diameter

5.5mm

6.5mm

7.5mm

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* 14. Screw Length

35mm

40mm

45mm

50mm

55mm

60mm

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* 15. Rod Length (35mm-130mm in 5mm increments)

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* 16. Rod

Straight

Precurved

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* 17. Rod Style

MIS (Features on End)

Standard

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* 18. Rate Each Instrument

	Below Average	Average	Above Average	Exceptional
Jamshidi	Jamshidi Below Average	Jamshidi Average	Jamshidi Above Average	Jamshidi Exceptional
K-Wire	K-Wire Below Average	K-Wire Average	K-Wire Above Average	K-Wire Exceptional
Dilators	Dilators Below Average	Dilators Average	Dilators Above Average	Dilators Exceptional
Taps	Taps Below Average	Taps Average	Taps Above Average	Taps Exceptional
Pedicle Screw Driver	Pedicle Screw Driver Below Average	Pedicle Screw Driver Average	Pedicle Screw Driver Above Average	Pedicle Screw Driver Exceptional
Snap Rings (if used)	Snap Rings (if used) Below Average	Snap Rings (if used) Average	Snap Rings (if used) Above Average	Snap Rings (if used) Exceptional
Snap Sleeves (if used)	Snap Sleeves (if used) Below Average	Snap Sleeves (if used) Average	Snap Sleeves (if used) Above Average	Snap Sleeves (if used) Exceptional
Dissector/Letter Opener	Dissector/Letter Opener Below Average	Dissector/Letter Opener Average	Dissector/Letter Opener Above Average	Dissector/Letter Opener Exceptional
Percutaneous Rod Holder	Percutaneous Rod Holder Below Average	Percutaneous Rod Holder Average	Percutaneous Rod Holder Above Average	Percutaneous Rod Holder Exceptional
Pituitary-Style Rod Holder	Pituitary-Style Rod Holder Below Average	Pituitary-Style Rod Holder Average	Pituitary-Style Rod Holder Above Average	Pituitary-Style Rod Holder Exceptional
Kerrison-Style Rod Holder	Kerrison-Style Rod Holder Below Average	Kerrison-Style Rod Holder Average	Kerrison-Style Rod Holder Above Average	Kerrison-Style Rod Holder Exceptional
Rod Calipers	Rod Calipers Below Average	Rod Calipers Average	Rod Calipers Above Average	Rod Calipers Exceptional
Stab-and-Grab Drivers for Locking Cap	Stab-and-Grab Drivers for Locking Cap Below Average	Stab-and-Grab Drivers for Locking Cap Average	Stab-and-Grab Drivers for Locking Cap Above Average	Stab-and-Grab Drivers for Locking Cap Exceptional
3.5-to-1 speed Driver	3.5-to-1 speed Driver Below Average	3.5-to-1 speed Driver Average	3.5-to-1 speed Driver Above Average	3.5-to-1 speed Driver Exceptional
Anti-Torque (Low-profile style, if used)	Anti-Torque (Low-profile style, if used) Below Average	Anti-Torque (Low-profile style, if used) Average	Anti-Torque (Low-profile style, if used) Above Average	Anti-Torque (Low-profile style, if used) Exceptional
Compressor/Distractor	Compressor/Distractor Below Average	Compressor/Distractor Average	Compressor/Distractor Above Average	Compressor/Distractor Exceptional
Tab Remover	Tab Remover Below Average	Tab Remover Average	Tab Remover Above Average	Tab Remover Exceptional

Please explain any below average ratings.

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* 19. Rate Each Implant

	Below Average	Average	Above Average	Exceptional
Length of Break-Away Towers	Length of Break-Away Towers Below Average	Length of Break-Away Towers Average	Length of Break-Away Towers Above Average	Length of Break-Away Towers Exceptional
Ease of Placing Screws	Ease of Placing Screws Below Average	Ease of Placing Screws Average	Ease of Placing Screws Above Average	Ease of Placing Screws Exceptional
Range of Screw Sizes Offered	Range of Screw Sizes Offered Below Average	Range of Screw Sizes Offered Average	Range of Screw Sizes Offered Above Average	Range of Screw Sizes Offered Exceptional
Range of Rod Lengths Offered	Range of Rod Lengths Offered Below Average	Range of Rod Lengths Offered Average	Range of Rod Lengths Offered Above Average	Range of Rod Lengths Offered Exceptional
Ease of Rod Placement	Ease of Rod Placement Below Average	Ease of Rod Placement Average	Ease of Rod Placement Above Average	Ease of Rod Placement Exceptional
Ease of Locking Cap Placement	Ease of Locking Cap Placement Below Average	Ease of Locking Cap Placement Average	Ease of Locking Cap Placement Above Average	Ease of Locking Cap Placement Exceptional
Range of Reduction	Range of Reduction Below Average	Range of Reduction Average	Range of Reduction Above Average	Range of Reduction Exceptional
Ease of Rod Reduction	Ease of Rod Reduction Below Average	Ease of Rod Reduction Average	Ease of Rod Reduction Above Average	Ease of Rod Reduction Exceptional
Overall Satisfaction with the System	Overall Satisfaction with the System Below Average	Overall Satisfaction with the System Average	Overall Satisfaction with the System Above Average	Overall Satisfaction with the System Exceptional

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* 1. Hospital Name

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* 2. Address

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* 3. Physician Name

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* 4. Patient Gender

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* 5. Patient Age

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* 6. Patient Weight

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* 7. Patient Height

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* 8. Surgery for this level

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* 9. Fusion Procedure

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* 10. Screw Placement Technique

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* 11. Operation Date and Time

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* 12. Total Operative Time (00:00)

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* 13. Screw Diameter

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* 14. Screw Length

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* 15. Rod Length (35mm-130mm in 5mm increments)

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* 16. Rod

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* 17. Rod Style

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* 18. Rate Each Instrument

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* 19. Rate Each Implant

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* 20. Any other suggestions for possible future improvements?

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* 21. Todays Date

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* 22. Your Name