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: (b)(6) index procedure was performed on (b)(6) 2023 apifix was notified that patient #748 (b)(6) was seen in the clinic on (b)(6) 2023 and x-rays showed that the apifix rod was broken.Patient experienced an acute onset of pain the week prior to being seen in clinic.Surgeon plans to do a revision in (b)(6) 2024 by replacing to a new rod.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).Re-operation events are a known risk that was assessed and recorded by the product risk assessment.The risk of mechanical failure of the mid-c mechanism - [implant breakage] has been assessed and found to be acceptable.The 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 clinical evaluation report.The explanted device is expected to be returned to the manufacturer for analysis after the revision surgery.Upon completion of the evaluations, when additional information comes to light, then a supplemental medwatch report will be submitted.
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On 01-feb-2024 apifix was notified that patient (b)(6) underwent revision surgery on that day, (b)(6) 2024.According to the reporter, there was gray around the area where the rod broke (right where the device distracts).The surgical aite at the time of removal was described as 'metallic debris around the broken area.A tissue sample was collected for analysis.Device is expected to be returned to manufacturer for evaluation.
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