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: on 29-feb-2024 apifix was notified that patient #(b)(6) (index procedure 04-dec-2020) is scheduled for revision surgery of 05-apr-2024 due to a broken rod (male portion of the ratchet mechanism).Minimal symptoms.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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