TPLC - Total Product Life Cycle

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Device	injector, vertebroplasty (does not contain cement)
Regulation Description	Cement dispenser.
Definition	Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Product Code	OAR
Regulation Number	888.4200
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	45	83
Adverse Event Without Identified Device or Use Problem	9	9
Break	8	8
Fluid/Blood Leak	6	6
Entrapment of Device	4	4
Detachment of Device or Device Component	4	6
Failure to Eject	3	3
Chemical Problem	1	1
Difficult to Remove	1	1
Failure to Deliver	1	1
Material Fragmentation	1	1
Material Separation	1	1
Improper Chemical Reaction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	50	80
Foreign Body In Patient	25	57
Insufficient Information	6	6
Nerve Damage	4	4
Joint Laxity	3	3
Unspecified Tissue Injury	3	3
Osteolysis	2	2
Non-union Bone Fracture	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Bone Fracture(s)	1	1
Stenosis	1	1
Device Embedded In Tissue or Plaque	1	1