TPLC - Total Product Life Cycle

show TPLC since

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	183	183
Migration	105	105
Break	93	93
Mechanical Problem	86	86
Mechanics Altered	65	65
Material Deformation	58	59
Insufficient Information	31	31
Collapse	30	30
Mechanical Jam	27	27
Activation Failure	27	27
Patient Device Interaction Problem	19	19
Material Integrity Problem	18	18
No Apparent Adverse Event	18	18
Fracture	16	16
Detachment of Device or Device Component	14	14
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
Unintended Movement	8	8
Material Twisted/Bent	8	8
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
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Material Separation	4	4
Improper or Incorrect Procedure or Method	3	3
Naturally Worn	3	3
Scratched Material	3	3
Device Damaged by Another Device	3	3
Noise, Audible	2	2
Premature Activation	2	2
Loose or Intermittent Connection	2	3
Problem with Sterilization	2	2
Positioning Failure	2	2
Degraded	2	2
Difficult to Remove	2	2
Therapeutic or Diagnostic Output Failure	2	2
Crack	2	2
Device-Device Incompatibility	2	2
Activation, Positioning or Separation Problem	2	2
Failure to Cut	1	1
Structural Problem	1	1
Inflation Problem	1	1
Difficult to Insert	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	425	426
Insufficient Information	74	74
Pain	52	52
No Known Impact Or Consequence To Patient	43	43
Failure of Implant	39	39
Non-union Bone Fracture	38	38
No Code Available	32	32
Bone Fracture(s)	26	26
Nerve Damage	25	25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
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
Vertebral Fracture	4	4
Hypersensitivity/Allergic reaction	4	4
Nervous System Injury	4	4
Blood Loss	4	4
Foreign Body In Patient	4	4
Paralysis	4	4
Ambulation Difficulties	3	3
Loss of consciousness	3	3
Joint Laxity	3	3
Peripheral Nervous Injury	3	3
Thrombosis/Thrombus	3	3
Spinal Column Injury	3	3
Neuropathy	3	3
Impaired Healing	3	3
Pneumothorax	3	3
Cyst(s)	3	3
Bowel Perforation	3	3
Nicks, cuts or tears of dura or other tissues by device	3	3
Oversedation	2	2
Unspecified Nervous System Problem	2	2
Pleural Effusion	2	2
Decreased Sensitivity	2	2
Unspecified Vascular Problem	2	2