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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 17 22

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 31 57
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
Failure to Eject 3 3
Difficult to Remove 3 3
Use of Device Problem 2 2
Material Separation 2 2
Chemical Problem 1 1
Material Fragmentation 1 1
Delivered as Unsterile Product 1 1
Activation Failure 1 2
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 18 40
Insufficient Information 7 10
No Consequences Or Impact To Patient 7 9
Nerve Damage 4 4
Device Embedded In Tissue or Plaque 4 4
No Known Impact Or Consequence To Patient 3 5
Unspecified Tissue Injury 3 3
Joint Laxity 3 3
No Patient Involvement 2 2
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
Extravasation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Merit Medical Systems, Inc. II Oct-11-2024
2 Merit Medical Systems, Inc. II May-21-2020
3 Stryker Corporation II Jul-03-2024
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