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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 CodeOAR
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

Device Problems MDRs with this Device Problem Events in those MDRs
Break 24 25
Fracture 18 36
Use of Device Problem 4 4
Detachment of Device or Device Component 3 5
Difficult to Remove 3 3
Material Separation 2 2
Fluid/Blood Leak 2 2
Entrapment of Device 2 2
Delivered as Unsterile Product 1 1
Chemical Problem 1 1
Contamination /Decontamination Problem 1 1
Activation Failure 1 2
Failure to Eject 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 43
Foreign Body In Patient 17 35
No Consequences Or Impact To Patient 9 11
Device Embedded In Tissue or Plaque 5 5
No Patient Involvement 3 3
No Known Impact Or Consequence To Patient 3 5
Insufficient Information 3 6
Nerve Damage 2 2
Blood Loss 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
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