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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
2019 14 15
2020 5 11
2021 13 24
2022 11 14
2023 14 17
2024 13 19

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 28 55
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 39 67
Foreign Body In Patient 17 40
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
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