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
2018	11	11
2019	14	15
2020	5	11
2021	13	24
2022	11	14
2023	10	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	24	25
Fracture	21	40
Fluid/Blood Leak	6	6
Use of Device Problem	4	4
Detachment of Device or Device Component	4	6
Entrapment of Device	3	3
Difficult to Remove	3	3
Material Separation	2	2
Failure to Eject	2	2
Improper Chemical Reaction	1	1
Activation Failure	1	2
Chemical Problem	1	1
Contamination /Decontamination Problem	1	1
Material Fragmentation	1	1
Delivered as Unsterile Product	1	1
Unsealed Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	32	52
Foreign Body In Patient	18	36
No Consequences Or Impact To Patient	9	11
Device Embedded In Tissue or Plaque	6	6
No Known Impact Or Consequence To Patient	3	5
No Patient Involvement	3	3
Insufficient Information	3	6
Blood Loss	2	2
Nerve Damage	2	2
Extravasation	1	1
No Code Available	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Sofamor Danek USA Inc	II	Jan-14-2018
2	Merit Medical Systems, Inc.	II	May-21-2020
3	Stryker Instruments Div. of Stryker Corporation	II	Mar-28-2018