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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)
Regulation Description Cement dispenser.
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

Device Problems
Break 36
Use of Device Problem 5
Device Operates Differently Than Expected 4
Adverse Event Without Identified Device or Use Problem 4
Fracture 2
Leak / Splash 2
Material Integrity Problem 2
Retraction Problem 1
Torn Material 1
Delivered as Unsterile Product 1
Detachment Of Device Component 1
Fluid Leak 1
Material Separation 1
Activation Failure Including Expansion Failures 1
Unsealed Device Packaging 1
Appropriate Term/Code Not Available 1
Contamination / decontamination Problem 1
Material Fragmentation 1
Total Device Problems 66

Manufacturer Recall Class Date Posted
1 Medtronic Sofamor Danek USA Inc II Jan-14-2018
2 Medtronic Sofamor Danek USA Inc II Jun-03-2017
3 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018