Production process data analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to apifix specifications.User (surgeon) information analysis: the follow up x-ray from (b)(6) 2021 demonstrates extender misalignment with an angle over 45 degrees.In addition, the distance from the extender's head to the pedicle screw is way over 4-5 mm apifix recommend.Corrective action: the company introduced the use of the extender component (eco 18) in (b)(6) 2017 and experienced a learning curve with its use.Extender misalignment results from not properly aligning the extender and the main rod, from selecting improper screw size to anchor the extender or from fault in the off the shelf tool used to lock the extender screws.The event may be associated with curve progression, implant migration and prominence.The company took several actions to mitigate extender misalignment: in (b)(6) 2018, a letter instructing surgeons how to properly align the extender was issued.Eco 48, a pre-bent extender was introduced to ease extender alignment.Eco 63, an extender-main rod angle measurement tool was added to the surgical tool.The current case was one of the first cases performed with an extender, prior to any of the company's mitigation for use of the extender.Risk assessment: he root cause for the prominence of the extender is its misalignment and hence it is classified accordingly.At the time of this report ((b)(6) 2021), the company's incident rate of extender misalignment is 2.4%.The risk of "extender and mid-c system not properly aligned" has been assessed and found to be acceptable (dms# (b)(4).Hazard id (b)(6)).
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