Production process analysis: a review of the device history record confirmed that the device was manufactured and tested according to relevant procedures, and shipped according to manufacturer's specifications.User (surgeon and patient) information analysis: patient (b)(6) index procedure performed on (b)(6) 2022.On (b)(6) 2023 apifix was notified that patient(b)(6) has a broken implant and is scheduled for revision to a new apifix device on 21-oct-2023.It was further noted that 'at the last appointment, in may, the apifix had already reached the stretching limit and i had recommended a replacement to the parents.At this moment, the curve is 36º, sanders 7.The risk of progression is still 47%.The apifix that was initially placed is already 125mm, so i will have to lower it one level to t5-t6.' on 21-oct-2023 patient (b)(6) underwent revision surgery during which the mid-c and extender were replaced.No report of patient harm/complication was received.Risk assessment: implant breakage can result from trauma, practicing contact or high demand sports, hyper-kyphosis, inserting the pedicle screws in a wrong trajectory which locks the poly-axial joints, not working according to the surgical technique (e.G., minimally invasive approach and/or not using the trial tool properly).The risk for breakage due to the above increases when the implant reaches its maximal elongation.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of broken rod has been assessed and found to be acceptable the current implant breakage rate due to any reason is in line with the rate reported in the literature for this type of complication as described in the company's cer (clinical evaluation report).The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.Apifix is closing this complaint at this time, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If new relevant information is made available, apifix will update the complaint record and file a follow up medwatch report.
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Return analysis: the explanted device was returned to orthopediatrics in warsaw, in and was subjected to cleaning, steam sterilizing, and engineering evaluation.The device was obviously fractured in the pole component around the mid-point of the pole.It appears that post fracture the device remained implanted as the fracture plane, inside of body, and side of pole showed signs of wear.The fracture plane was worn completely smooth from and thus fracture mode is not able to be identified.The spherical rings appeared in good condition with no wear visibly observed.
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