TPLC - Total Product Life Cycle

Device	spinal vertebral body replacement device
Regulation Description	Spinal intervertebral body fixation orthosis.
Product Code	MQP
Regulation Number	888.3060
Device Class	2

Premarket Reviews
Manufacturer	Decision
AESCULAP
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC
	SUBSTANTIALLY EQUIVALENT	1
ATLAS SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET
	SUBSTANTIALLY EQUIVALENT	1
BLACKSTONE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	6
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	12
EBI, L.P.
	SUBSTANTIALLY EQUIVALENT	6
ENCORE MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS
	SUBSTANTIALLY EQUIVALENT	8
IMPLEX
	SUBSTANTIALLY EQUIVALENT	8
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE SPINAL TECHNOLOGIES INC
	SUBSTANTIALLY EQUIVALENT	1
INTERPORE CROSS
	SUBSTANTIALLY EQUIVALENT	10
LANX
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	30
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
NUVASIVE
	SUBSTANTIALLY EQUIVALENT	5
ORTHO DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	1
ORTHOVITA
	SUBSTANTIALLY EQUIVALENT	1
OSTEOTECH, INC.
	SUBSTANTIALLY EQUIVALENT	4
PIONEER
	SUBSTANTIALLY EQUIVALENT	2
SCIENT'X
	SUBSTANTIALLY EQUIVALENT	1
SPINAL CONCEPTS
	SUBSTANTIALLY EQUIVALENT	5
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	8
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	9
SURGICRAFT CO.
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES
	SUBSTANTIALLY EQUIVALENT	6
THEKEN SPINE
	SUBSTANTIALLY EQUIVALENT	5
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
VERTEBRON, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	5

Device Problems
Break	104
Implant breakage or physical damage	31
Migration of device or device component	27
Device remains implanted	19
Implant, removal of	18
Implant, repositioning of	18
Explanted	15
Device, or device fragments remain in patient	14
No Known Device Problem	8
Fracture	5
Material discolored	5
Detachment of device component	4
Slippage of device or device component	4
Malposition of device	4
Crack	3
Disconnection	3
Dislodged	3
Loose or intermittent connection	2
Disengaged	2
Malfunction	2
Detachment of device or device component	2
Implant Mobility NOS (Not otherwise specified)	2
Mechanical issue	2
No code available	2
No Information	1
Device markings issue	1
Difficult to open or close	1
Dislodged or dislocated	1
Failure to align	1
Failure to advance	1
Device or device fragments location unknown	1
Device inoperable	1
Improper or incorrect procedure or method	1
Unknown (for use when the device problem is not known)	1
Replace	1
Normal	1
Collapse	1
Component(s), broken	1
Difficult to deploy	1
Failure to deploy	1
Disassembly	1
Failure to discharge	1
Loose	1
Markings unclear	1
Material fragmentation	1
Shock, electrical	1
Flaked	1
Foreign material	1
Total Device Problems	323