TPLC - Total Product Life Cycle

• Device: injector, vertebroplasty (does not contain cement)
• 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

MDR Year	MDR Reports	MDR Events
2019	14	15
2020	5	11
2021	13	24
2022	11	14
2023	14	17
2024	10	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	25	47
Break	16	17
Adverse Event Without Identified Device or Use Problem	9	9
Fluid/Blood Leak	6	6
Detachment of Device or Device Component	4	6
Entrapment of Device	3	3
Difficult to Remove	3	3
Material Separation	2	2
Use of Device Problem	2	2
Failure to Eject	2	2
Improper Chemical Reaction	1	1
Activation Failure	1	2
Chemical Problem	1	1
Material Fragmentation	1	1
Delivered as Unsterile Product	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	36	59
Foreign Body In Patient	16	35
No Consequences Or Impact To Patient	7	9
Insufficient Information	7	10
Device Embedded In Tissue or Plaque	4	4
Nerve Damage	4	4
Joint Laxity	3	3
Unspecified Tissue Injury	3	3
No Known Impact Or Consequence To Patient	3	5
Non-union Bone Fracture	2	2
Osteolysis	2	2
No Patient Involvement	2	2
Extravasation	1	1
Bone Fracture(s)	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Merit Medical Systems, Inc.	II	May-21-2020