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	32	59
Adverse Event Without Identified Device or Use Problem	9	9
Fluid/Blood Leak	6	6
Break	5	5
Detachment of Device or Device Component	4	6
Entrapment of Device	3	3
Failure to Eject	3	3
Difficult to Remove	2	2
Chemical Problem	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	42	69
Foreign Body In Patient	17	39
Insufficient Information	7	10
Nerve Damage	4	4
Joint Laxity	3	3
Unspecified Tissue Injury	3	3
No Known Impact Or Consequence To Patient	2	4
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
No Consequences Or Impact To Patient	1	2
Device Embedded In Tissue or Plaque	1	1