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
FOUNDATION SURGICAL GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	136	137
Break	117	117
Mechanical Problem	108	109
Migration	74	75
Material Deformation	60	61
Mechanics Altered	60	60
Collapse	30	30
Insufficient Information	30	30
Mechanical Jam	22	22
Activation Failure	18	18
Material Integrity Problem	17	17
Patient Device Interaction Problem	17	17
Detachment of Device or Device Component	15	15
Compatibility Problem	12	12
Product Quality Problem	12	12
Fracture	11	12
Device Dislodged or Dislocated	10	10
Connection Problem	8	8
Activation Problem	8	8
Failure to Advance	7	8
Degraded	7	7
Material Twisted/Bent	6	6
Device Slipped	5	5
Appropriate Term/Code Not Available	4	4
Material Separation	4	4
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Unintended Movement	4	4
Output Problem	4	4
Malposition of Device	4	4
Migration or Expulsion of Device	4	4
Use of Device Problem	3	3
Scratched Material	3	3
No Apparent Adverse Event	3	3
Crack	3	3
Naturally Worn	3	3
Improper or Incorrect Procedure or Method	3	3
Positioning Failure	2	2
Problem with Sterilization	2	2
Device Damaged by Another Device	2	2
Difficult to Remove	2	2
Therapeutic or Diagnostic Output Failure	2	2
Device-Device Incompatibility	2	2
Activation, Positioning or Separation Problem	2	2
Premature Activation	2	2
Noise, Audible	2	2
Material Fragmentation	1	1
Failure to Cut	1	1
Inflation Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Overcorrection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	457	459
Insufficient Information	73	73
Non-union Bone Fracture	36	36
Pain	36	37
Failure of Implant	30	30
Nerve Damage	25	25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	23
Unspecified Tissue Injury	19	19
Bone Fracture(s)	19	20
Post Operative Wound Infection	19	19
Osteolysis	18	18
Hematoma	16	16
Unspecified Infection	15	15
Cerebrospinal Fluid Leakage	12	12
Hemorrhage/Bleeding	8	8
Dysphagia/ Odynophagia	8	8
Perforation of Vessels	6	6
Neck Pain	6	6
Physical Asymmetry	5	5
Device Embedded In Tissue or Plaque	4	4
Ambulation Difficulties	4	4
Vertebral Fracture	4	4
Nervous System Injury	4	4
Spinal Cord Injury	4	4
Stenosis	4	4
Pleural Effusion	4	4
Foreign Body In Patient	4	4
Oversedation	4	4
Spinal Column Injury	4	4
Impaired Healing	3	3
Unspecified Nervous System Problem	3	3
Paralysis	3	3
Thrombosis/Thrombus	3	3
Loss of consciousness	3	3
Pneumothorax	3	3
Joint Laxity	3	3
Peripheral Nervous Injury	3	3
Nicks, cuts or tears of dura or other tissues by device	3	3
Unspecified Vascular Problem	2	2
Decreased Sensitivity	2	2
Intervertebral Disc Compression or Protrusion	2	2
Speech Disorder	2	2
Cyst(s)	2	2
Bowel Perforation	2	2
Laceration(s)	2	2
Inadequate Osseointegration	2	2
Abscess	2	2
Hypovolemic Shock	1	1
Urinary Tract Infection	1	1
Pulmonary Embolism	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	NuVasive Inc	II	Dec-20-2022