TPLC - Total Product Life Cycle

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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
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARFTX MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	1
FOUNDATION SURGICAL GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	2
NU VASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	183	184
Migration	105	106
Break	99	99
Mechanical Problem	89	90
Mechanics Altered	66	66
Material Deformation	58	59
Collapse	31	31
Insufficient Information	31	31
Mechanical Jam	27	27
Activation Failure	27	27
Patient Device Interaction Problem	19	19
No Apparent Adverse Event	18	18
Material Integrity Problem	18	18
Fracture	16	17
Detachment of Device or Device Component	14	14
Device Dislodged or Dislocated	13	13
Compatibility Problem	12	12
Product Quality Problem	11	11
Migration or Expulsion of Device	10	10
Connection Problem	8	8
Malposition of Device	8	8
Activation Problem	8	8
Unintended Movement	8	8
Material Twisted/Bent	8	8
Use of Device Problem	7	7
Failure to Advance	6	7
Appropriate Term/Code Not Available	5	5
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Crack	4	4
Material Separation	4	4
Output Problem	4	4
Device Slipped	4	4
Scratched Material	3	3
Device Damaged by Another Device	3	3
Naturally Worn	3	3
Improper or Incorrect Procedure or Method	3	3
Difficult to Remove	2	2
Degraded	2	2
Positioning Failure	2	2
Therapeutic or Diagnostic Output Failure	2	2
Problem with Sterilization	2	2
Device-Device Incompatibility	2	2
Activation, Positioning or Separation Problem	2	2
Loose or Intermittent Connection	2	3
Premature Activation	2	2
Noise, Audible	2	2
Material Fragmentation	1	1
Difficult to Insert	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Difficult to Advance	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	435	437
Insufficient Information	74	74
Pain	52	53
No Known Impact Or Consequence To Patient	43	43
Failure of Implant	40	40
Non-union Bone Fracture	38	38
No Code Available	32	32
Bone Fracture(s)	26	27
Nerve Damage	25	25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	23
Unspecified Infection	21	21
Post Operative Wound Infection	20	20
Unspecified Tissue Injury	18	18
Hematoma	18	18
Osteolysis	17	17
Dysphagia/ Odynophagia	16	16
Cerebrospinal Fluid Leakage	13	13
Hemorrhage/Bleeding	8	8
Perforation of Vessels	8	8
No Consequences Or Impact To Patient	7	7
Stenosis	6	6
Neck Pain	6	6
Spinal Cord Injury	5	5
Therapeutic Effects, Unexpected	5	5
Physical Asymmetry	5	5
Injury	5	5
Device Embedded In Tissue or Plaque	4	4
Blood Loss	4	4
Spinal Column Injury	4	4
Vertebral Fracture	4	4
Nervous System Injury	4	4
Foreign Body In Patient	4	4
Paralysis	4	4
Oversedation	4	4
Hypersensitivity/Allergic reaction	4	4
Pneumothorax	3	3
Ambulation Difficulties	3	3
Peripheral Nervous Injury	3	3
Joint Laxity	3	3
Cyst(s)	3	3
Nicks, cuts or tears of dura or other tissues by device	3	3
Thrombosis/Thrombus	3	3
Neuropathy	3	3
Loss of consciousness	3	3
Bowel Perforation	3	3
Impaired Healing	3	3
Abscess	2	2
Laceration(s)	2	2
Speech Disorder	2	2
Pleural Effusion	2	2