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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 33
Use of Device Problem 5
Adverse Event Without Identified Device or Use Problem 4
Device Operates Differently Than Expected 4
Fracture 2
Material Integrity Problem 2
Leak / Splash 2
Detachment Of Device Component 1
Material Fragmentation 1
Unsealed Device Packaging 1
Fluid Leak 1
Torn Material 1
Delivered as Unsterile Product 1
Contamination / decontamination Problem 1
Appropriate Term/Code Not Available 1
Retraction Problem 1
Total Device Problems 61

Recalls
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

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