TPLC - Total Product Life Cycle

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Device	spinal vertebral body replacement device
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
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE
	SUBSTANTIALLY EQUIVALENT	1
CMF MEDICON SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SYNTHES SPINE
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK, USA INC.
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
ULRICH GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	192	192
Migration	115	115
Break	75	75
Mechanics Altered	63	63
Material Deformation	37	38
Insufficient Information	29	29
Mechanical Problem	27	27
Collapse	27	27
Activation Failure	27	27
Mechanical Jam	24	24
Migration or Expulsion of Device	21	21
No Apparent Adverse Event	21	21
Fracture	20	20
Device Dislodged or Dislocated	18	18
Appropriate Term/Code Not Available	17	17
Patient Device Interaction Problem	17	17
Material Integrity Problem	16	16
Detachment of Device or Device Component	13	13
Compatibility Problem	12	12
Material Twisted/Bent	10	10
Malposition of Device	9	9
Connection Problem	8	8
Unintended Movement	8	8
Device Slipped	7	7
Activation Problem	7	7
Use of Device Problem	6	6
Material Separation	5	5
Device-Device Incompatibility	4	4
Output Problem	4	4
Scratched Material	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Material Fragmentation	3	3
Device Damaged by Another Device	3	3
Noise, Audible	2	2
Premature Activation	2	2
Improper or Incorrect Procedure or Method	2	2
Loose or Intermittent Connection	2	2
Naturally Worn	2	2
Failure to Advance	2	2
Product Quality Problem	2	2
Positioning Failure	2	2
Difficult to Insert	2	2
Degraded	2	2
Difficult to Remove	2	2
Therapeutic or Diagnostic Output Failure	2	2
Activation, Positioning or Separation Problem	2	2
Inflation Problem	1	1
Failure to Cut	1	1
Structural Problem	1	1
Inadequacy of Device Shape and/or Size	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	304	305
No Code Available	70	70
Insufficient Information	62	62
No Known Impact Or Consequence To Patient	61	61
Pain	55	55
Failure of Implant	51	51
Non-union Bone Fracture	35	35
Nerve Damage	28	28
Unspecified Infection	25	25
Bone Fracture(s)	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Dysphagia/ Odynophagia	18	18
Post Operative Wound Infection	18	18
Unspecified Tissue Injury	17	17
Hematoma	17	17
No Consequences Or Impact To Patient	15	15
Osteolysis	14	14
Cerebrospinal Fluid Leakage	11	11
Injury	11	11
Perforation of Vessels	8	8
Paralysis	8	8
Foreign Body In Patient	6	6
Neck Pain	6	6
Spinal Cord Injury	5	5
Therapeutic Effects, Unexpected	5	5
Hemorrhage/Bleeding	5	5
Physical Asymmetry	5	5
Blood Loss	5	5
Nervous System Injury	4	4
Stenosis	4	4
Abscess	4	4
Loss of consciousness	3	3
Peripheral Nervous Injury	3	3
Thrombosis/Thrombus	3	3
Neuropathy	3	3
Hypersensitivity/Allergic reaction	3	3
Ambulation Difficulties	2	2
Oversedation	2	2
Unspecified Nervous System Problem	2	2
Spinal Column Injury	2	2
Vertebral Fracture	2	2
Edema	2	2
Discomfort	2	2
Unspecified Vascular Problem	2	2
Speech Disorder	2	2
Laceration(s)	2	2
Visual Impairment	2	2
Pneumonia	2	2
Reaction	2	2
Device Embedded In Tissue or Plaque	1	1