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
NUVASIVE 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	175	175
Migration	103	103
Break	83	83
Mechanical Problem	76	76
Mechanics Altered	65	65
Material Deformation	53	54
Insufficient Information	31	31
Collapse	29	29
Activation Failure	27	27
Mechanical Jam	26	26
Patient Device Interaction Problem	19	19
No Apparent Adverse Event	18	18
Material Integrity Problem	16	16
Fracture	14	14
Detachment of Device or Device Component	13	13
Compatibility Problem	12	12
Device Dislodged or Dislocated	12	12
Migration or Expulsion of Device	10	10
Product Quality Problem	9	9
Malposition of Device	8	8
Activation Problem	8	8
Connection Problem	8	8
Material Twisted/Bent	8	8
Unintended Movement	7	7
Use of Device Problem	7	7
Appropriate Term/Code Not Available	5	5
Failure to Advance	5	5
Device Slipped	4	4
Output Problem	4	4
Material Separation	4	4
Improper or Incorrect Procedure or Method	3	3
Scratched Material	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Device Damaged by Another Device	3	3
Noise, Audible	2	2
Premature Activation	2	2
Loose or Intermittent Connection	2	2
Naturally Worn	2	2
Positioning Failure	2	2
Degraded	2	2
Difficult to Remove	2	2
Therapeutic or Diagnostic Output Failure	2	2
Crack	2	2
Activation, Positioning or Separation Problem	2	2
Failure to Cut	1	1
Inflation Problem	1	1
Structural Problem	1	1
Difficult to Insert	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Fragmentation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	395	396
Insufficient Information	69	69
Pain	49	49
No Known Impact Or Consequence To Patient	43	43
Non-union Bone Fracture	37	37
Failure of Implant	37	37
No Code Available	32	32
Bone Fracture(s)	26	26
Nerve Damage	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Unspecified Infection	20	20
Post Operative Wound Infection	20	20
Unspecified Tissue Injury	18	18
Hematoma	18	18
Dysphagia/ Odynophagia	16	16
Osteolysis	16	16
Cerebrospinal Fluid Leakage	13	13
Perforation of Vessels	8	8
Hemorrhage/Bleeding	8	8
No Consequences Or Impact To Patient	7	7
Neck Pain	6	6
Physical Asymmetry	5	5
Injury	5	5
Therapeutic Effects, Unexpected	5	5
Spinal Cord Injury	5	5
Blood Loss	4	4
Stenosis	4	4
Nervous System Injury	4	4
Device Embedded In Tissue or Plaque	4	4
Foreign Body In Patient	4	4
Paralysis	4	4
Cyst(s)	3	3
Loss of consciousness	3	3
Neuropathy	3	3
Peripheral Nervous Injury	3	3
Bowel Perforation	3	3
Spinal Column Injury	3	3
Vertebral Fracture	3	3
Hypersensitivity/Allergic reaction	3	3
Thrombosis/Thrombus	3	3
Pneumothorax	3	3
Abscess	2	2
Laceration(s)	2	2
Impaired Healing	2	2
Pleural Effusion	2	2
Speech Disorder	2	2
Ambulation Difficulties	2	2
Intervertebral Disc Compression or Protrusion	2	2
Oversedation	2	2
Inadequate Osseointegration	2	2